Surgical staples comprising hardness variations for improved fastening of tissue

ABSTRACT

A surgical staple cartridge is disclosed comprising a plurality of staples removably stored within the surgical staple cartridge. The staples comprise staple legs which extend from a staple base portion. The staple legs comprise staple tips configured to pierce tissue and contact a corresponding forming pocket of an anvil of surgical stapling instrument. The staples further comprise zones having different hardnesses.

CROSS-REFERENCE TO RELATED APPLICATION

This application is a continuation application claiming priority under35 U.S.C. § 120 to U.S. patent application Ser. No. 14/836,411, entitledSURGICAL STAPLES COMPRISING HARDNESS VARIATIONS FOR IMPROVED FASTENINGOF TISSUE, filed Aug. 26, 2015, now U.S. Patent Application PublicationNo. 2017/0056008, the entire disclosure of which is hereby incorporatedby reference herein.

BACKGROUND

The present invention relates to surgical instruments and, in variousembodiments, to surgical stapling and cutting instruments and staplecartridges for use therewith.

A stapling instrument can include a pair of cooperating elongate jawmembers, wherein each jaw member can be adapted to be inserted into apatient and positioned relative to tissue that is to be stapled and/orincised. In various embodiments, one of the jaw members can support astaple cartridge with at least two laterally spaced rows of staplescontained therein, and the other jaw member can support an anvil withstaple-forming pockets aligned with the rows of staples in the staplecartridge. Generally, the stapling instrument can further include apusher bar and a knife blade which are slidable relative to the jawmembers to sequentially eject the staples from the staple cartridge viacamming surfaces on the pusher bar and/or camming surfaces on a wedgesled that is pushed by the pusher bar. In at least one embodiment, thecamming surfaces can be configured to activate a plurality of stapledrivers carried by the cartridge and associated with the staples inorder to push the staples against the anvil and form laterally spacedrows of deformed staples in the tissue gripped between the jaw members.In at least one embodiment, the knife blade can trail the cammingsurfaces and cut the tissue along a line between the staple rows.

The foregoing discussion is intended only to illustrate various aspectsof the related art in the field of the invention at the time, and shouldnot be taken as a disavowal of claim scope.

BRIEF DESCRIPTION OF THE DRAWINGS

Various features of the embodiments described herein are set forth withparticularity in the appended claims. The various embodiments, however,both as to organization and methods of operation, together withadvantages thereof, may be understood in accordance with the followingdescription taken in conjunction with the accompanying drawings asfollows:

FIG. 1 is a perspective view of a staple for use with a surgicalstapling instrument in accordance with at least one embodiment;

FIG. 2 is a side elevation view of the staple of FIG. 1;

FIG. 3 is a top view of the staple of FIG. 1;

FIG. 4 is a cross-sectional view of the staple of FIG. 1 taken alongline 4-4 in FIG. 3;

FIG. 5 is a perspective view of a staple for use with a surgicalstapling instrument in accordance with at least one embodiment;

FIG. 6 is a side elevation view of the staple of FIG. 5;

FIG. 7 is a side elevation view of a staple for use with surgicalstapling instrument in accordance with at least one embodiment;

FIG. 8 is a side elevation view of the staple of FIG. 7 in a formedconfiguration;

FIG. 9 is a top view of the staple of FIG. 7 in the formed configurationof FIG. 8;

FIG. 10 is a side elevation view of the staple of FIG. 7 in a formedconfiguration and a partial cross-sectional view of an anvil of asurgical stapling instrument;

FIG. 11 is a perspective view of a staple for use with a surgicalstapling instrument in accordance with at least one embodiment;

FIGS. 11A-11C are cross-sections of portions of the staple of FIG. 11;

FIG. 12 is a perspective view of a staple for use with a surgicalstapling instrument in accordance with at least one embodiment;

FIG. 13 is a side elevation view of a staple for use with a surgicalstapling instrument in accordance with at least one embodiment;

FIG. 14 is a partial top view of a formed staple configurationcomprising a plurality of staples in accordance with at least oneembodiment;

FIG. 15 is a perspective view of a staple for use with a surgicalstapling instrument in accordance with at least one embodiment;

FIG. 16 is a partial cross-sectional view of an anvil illustrating aportion of the staple of FIG. 15 being formed from an unformedconfiguration to a formed configuration;

FIG. 17 is an elevation view of the staple of FIG. 15 in a formedconfiguration;

FIG. 18 includes side views of multiple staple tips in accordance withat least one embodiment;

FIG. 19 is a bottom view of a staple in accordance with at least oneembodiment and forming pockets of an anvil according to a firstarrangement;

FIG. 20 is partial cross-sectional view of an anvil pocket of FIG. 19taken along line 20-20 in FIG. 19;

FIG. 21 is a bottom view of the staple and the forming pockets of FIG.19 according to a second arrangement;

FIG. 22 is a bottom view of the staple and the forming pockets of FIG.19 according to a third arrangement;

FIG. 23 is a bottom view of the staple of FIG. 19 and forming pockets inaccordance with at least one embodiment;

FIG. 24 is a partial cross-sectional view of an anvil pocket of FIG. 23taken along line 24-24 in FIG. 23;

FIG. 25 is a bottom view of the staple of FIG. 19 and forming pockets inaccordance with at least one embodiment;

FIG. 26 is a bottom view of the staple of FIG. 19 and forming pockets inaccordance with at least one embodiment;

FIG. 27 is a partial perspective view of a staple leg in accordance withat least one embodiment;

FIG. 27A is a partial cross-sectional end view of the staple leg of FIG.27;

FIG. 27B is a partial longitudinal cross-section of the staple leg ofFIG. 27;

FIG. 28 is a perspective view of a portion of a staple stripmanufactured with progressive die stamping;

FIG. 28A is a partial cross-sectional view of the portion of the staplestrip of FIG. 28 taken along line 28A-28A in FIG. 28;

FIG. 28B is a partial cross-sectional view of the portion of the staplestrip of FIG. 28 taken along line 28B-28B in FIG. 28;

FIG. 28C is a partial perspective view of a sled configured to engagethe staple strip of FIG. 28;

FIG. 29 is a perspective view of a portion of a staple stripmanufactured with progressive die stamping in accordance with at leastone embodiment;

FIG. 30 is a bottom perspective view of the staple strip of FIG. 29;

FIG. 31 is a partial cross-sectional view of a staple cartridge andstaples in accordance with at least one embodiment;

FIG. 32 is a perspective view of a staple cartridge assembly inaccordance with at least one embodiment;

FIG. 33 is a top plan view of the staple cartridge assembly of FIG. 32;

FIG. 34 is a detail view of a distal end of the staple cartridgeassembly of FIG. 32;

FIG. 35 is a partial cross-sectional perspective view of a staplecartridge assembly in accordance with at least one embodimentillustrating staples being ejected from the staple cartridge assembly bya firing member;

FIG. 36 is a partial exploded view of the staple cartridge assembly ofFIG. 35;

FIG. 37 is a partial cross-sectional view of the staple cartridgeassembly of FIG. 35 illustrating a staple being deformed against ananvil by the firing member;

FIG. 38 is a partial plan view of a staple positioned in a staple cavityof the staple cartridge assembly of FIG. 35;

FIG. 39 is a partial perspective view of a staple being lifted by thefiring member of the staple cartridge of FIG. 35;

FIG. 40 is a bottom perspective view of the staple of FIG. 39;

FIG. 41 is a diagram illustrating the staple of FIG. 39 in a levelposition;

FIG. 42 is a diagram illustrating the staple of FIG. 39 in a crookedposition;

FIG. 43 is a cross-sectional plan view of a staple cavity configured toguide a staple in accordance with at least one embodiment;

FIG. 44 is a cross-sectional perspective view of a staple cartridgeassembly positioned in a jaw of a surgical stapling instrument inaccordance with at least one embodiment illustrating a firing memberpositioned in a cartridge body of the staple cartridge assembly;

FIG. 45 is a partial cross-sectional perspective view of the staplecartridge assembly of FIG. 44 illustrating a retention featureconfigured to hold the firing member in the cartridge body when thestaple cartridge assembly is not positioned in the jaw of the surgicalstapling instrument;

FIG. 46 is a partial cross-sectional exploded view of the staplecartridge assembly of FIG. 44;

FIG. 47 is a partial cross-sectional end view of the staple cartridgeassembly of FIG. 44;

FIG. 48 is a partial cross-sectional perspective view of the staplecartridge assembly of FIG. 44 illustrating a retention featureconfigured to releasably hold the staple cartridge assembly in the jawof the surgical stapling instrument;

FIG. 49 is a partial plan view of a staple positioned in a staple cavityof a staple cartridge assembly in accordance with at least oneembodiment;

FIG. 50 is a detail view of a retention feature configured to releasablyhold the staple in the staple cartridge assembly of FIG. 49;

FIG. 51 is a partial cross-sectional elevational view of a staplecartridge assembly in accordance with at least one embodiment;

FIG. 52 is a perspective view of a staple in accordance with at leastone embodiment;

FIG. 53 is a bottom perspective view of the staple of FIG. 52;

FIG. 54 is a front elevational view of the staple of FIG. 52;

FIG. 55 is a side elevational view of the staple of FIG. 52;

FIG. 56 is a bottom view of the staple of FIG. 52;

FIG. 57 is a perspective view of a firing member of a staple cartridgeassembly in accordance with at least one embodiment comprising alignmentchannels;

FIG. 58 is a diagram illustrating the firing member of FIG. 57 and astaple positioned in a staple cavity of a staple cartridge assembly;

FIG. 59 is a diagram illustrating the firing member of FIG. 57 aligningthe staple of FIG. 58 within the staple cavity of FIG. 58;

FIG. 60 is a perspective view of the firing member of FIG. 57 andstaples arranged in two longitudinal rows;

FIG. 61 is a partial cross-sectional view of an alignment channel of thefiring member of FIG. 57 and a portion of the staple of FIG. 58;

FIG. 62 is a partial cross-sectional perspective view of the staplecartridge assembly of FIG. 58;

FIG. 63 is a partial exploded view of the staple cartridge assembly ofFIG. 58;

FIG. 64 is a partial bottom cross-sectional perspective view of thestaple cartridge assembly of FIG. 58;

FIG. 65 is a partial perspective view of projections extending from adeck surface of a staple cartridge assembly in accordance with at leastone alternative embodiment;

FIG. 66 is a partial perspective view of projections extending from adeck surface of a staple cartridge assembly in accordance with at leastone alternative embodiment;

FIG. 67 is a bottom perspective view of a cartridge body of a staplecartridge assembly;

FIG. 68 is a bottom view of the cartridge body of FIG. 67;

FIG. 69 is a bottom perspective view of the cartridge body of the staplecartridge assembly of FIG. 32;

FIG. 70 is a bottom view of the cartridge body of FIG. 32;

FIG. 71 is a diagram illustrating the cartridge body of FIG. 67 to analternative embodiment of a cartridge body;

FIG. 72 is a partial top plan view of a staple cartridge assembly inaccordance with at least one embodiment;

FIG. 73 is a partial perspective view of the staple cartridge of FIG.32;

FIG. 74 is a cross-sectional view of the staple cartridge of FIG. 32 andthe anvil of FIG. 37 illustrating certain staples in an unfired positionand certain staples in a fired position;

FIG. 75 illustrates the staples of the staple cartridge of FIG. 32deformed to three different heights;

FIG. 76 illustrates the staples of the staple cartridge of FIG. 32implanted in the tissue of a patient;

FIG. 77 illustrates a staple of the staple cartridge of FIG. 32 beingdeformed;

FIG. 78 is a perspective view of a staple in accordance with at leastone embodiment;

FIG. 79 is a cross-sectional view of the staple of FIG. 78;

FIG. 80 is a perspective view of a staple assembly in accordance with atleast one embodiment;

FIG. 81 is an elevational view of the staple assembly of FIG. 80;

FIG. 82 is a perspective view of an implantable staple adjunct;

FIG. 83 is a cross-sectional view of the staple adjunct of FIG. 82;

FIG. 84 is a partial perspective view of a staple assembly including thestaple adjunct of FIG. 82;

FIG. 85 illustrates the staple assembly of FIG. 84 implanted intotissue;

FIG. 86 is a perspective view of a staple in accordance with at leastone embodiment illustrated in a deformed configuration;

FIG. 87 is a plan view of a circular cartridge body comprising aplurality of the staple assemblies of FIG. 84 in accordance with atleast one embodiment;

FIG. 88 illustrates the spacing of the staples of FIG. 35 in unstretchedtissue;

FIG. 89 illustrates the spacing of the staples of FIG. 35 in stretchedtissue;

FIG. 90 is a perspective view of a staple in accordance with at leastone embodiment;

FIG. 91 illustrates the staple of FIG. 90 implanted into tissue;

FIG. 92 illustrates the staple of FIG. 90 after being partiallydissolved;

FIG. 93 is a cross-sectional perspective view of a portion of a circularsurgical stapler in accordance with at least one embodiment;

FIG. 94 is a partial cross-sectional perspective view of the circularsurgical stapler of FIG. 93;

FIG. 95 is a partial perspective view of the circular surgical staplerof FIG. 93;

FIG. 96 is a partial exploded perspective view of a circular surgicalstapler in accordance with at least one embodiment;

FIG. 97 is a partial perspective view of the circular surgical staplerof FIG. 96 illustrating staples in a preloaded position;

FIG. 98 is a partial perspective view of the circular surgical staplerof FIG. 96;

FIG. 99 is an end view of a circular surgical stapling configuration inaccordance with at least one embodiment;

FIG. 100 is an end view of a circular surgical stapling configuration inaccordance with at least one embodiment;

FIG. 101 is partial cross-sectional view of a colon stapled with acircular stapling instrument disclosed herein;

FIG. 102 is a partial perspective view of a curved stapler in accordancewith at least one embodiment;

FIG. 103 is a partial exploded view of the curved stapler of FIG. 102;

FIG. 104 is a partial perspective view of the curved stapler of FIG.102;

FIG. 105 is a partial perspective view of a curved stapler in accordancewith at least one embodiment; and

FIG. 106 is a partial perspective view of the curved stapler of FIG.105.

Corresponding reference characters indicate corresponding partsthroughout the several views. The exemplifications set out hereinillustrate various embodiments of the invention, in one form, and suchexemplifications are not to be construed as limiting the scope of theinvention in any manner.

DETAILED DESCRIPTION

The Applicant of the present application owns the following U.S. patentapplications that were filed on Aug. 26, 2015 and which are each hereinincorporated by reference in their respective entireties:

U.S. patent application Ser. No. 14/836,324, entitled SURGICAL STAPLESFOR MINIMIZING STAPLE ROLL, now U.S. Patent Application Publication No.2017/0056005;

U.S. patent application Ser. No. 14/836,020, entitled SURGICAL STAPLESCOMPRISING FEATURES FOR IMPROVED FASTENING OF TISSUE, now U.S. Pat. No.10,098,642;

U.S. patent application Ser. No. 14/836,058, entitled SURGICAL STAPLESTRIPS FOR PERMITTING VARYING STAPLE PROPERTIES AND ENABLING EASYCARTRIDGE LOADING, now U.S. Patent Application Publication No.2017/0055998;

U.S. patent application Ser. No. 14/836,110, entitled SURGICAL STAPLINGCONFIGURATIONS FOR CURVED AND CIRCULAR STAPLING INSTRUMENTS, now U.S.Patent Application Publication No. 2017/0056000;

U.S. patent application Ser. No. 14/836,036, entitled STAPLE CARTRIDGEASSEMBLY WITHOUT A BOTTOM COVER, now U.S. Pat. No. 10,213,203;

U.S. patent application Ser. No. 14/836,077, entitled STAPLE CARTRIDGEASSEMBLY COMPRISING STAPLE CAVITIES FOR PROVIDING BETTER STAPLEGUIDANCE, now U.S. Patent Application Publication No. 2017/0055999;

U.S. patent application Ser. No. 14/836,225, entitled STAPLE CARTRIDGEASSEMBLY INCLUDING STAPLE GUIDES, now U.S. Pat. No. 10,028,744;

U.S. patent application Ser. No. 14/836,351, entitled STAPLE CARTRIDGEASSEMBLY COMPRISING STAPLE ALIGNMENT FEATURES ON A FIRING MEMBER, nowU.S. Patent Application Publication No. 2017/0056006;

U.S. patent application Ser. No. 14/836,163, entitled STAPLE CARTRIDGEASSEMBLY COMPRISING VARIOUS TISSUE COMPRESSION GAPS AND STAPLE FORMINGGAPS, now U.S. Patent Application Publication No. 2017/0056002;

U.S. patent application Ser. No. 14/836,294, entitled STAPLES CONFIGUREDTO SUPPORT AN IMPLANTABLE ADJUNCT, now U.S. Pat. No. 10,188,394;

U.S. patent application Ser. No. 14/836,375, entitled STAPLES COMPRISINGA COVER, now U.S. Patent Application Publication No. 2017/0056007; and

U.S. patent application Ser. No. 14/836,137, entitled STAPLE CARTRIDGEASSEMBLY INCLUDING FEATURES FOR CONTROLLING THE ROTATION OF STAPLES WHENBEING EJECTED THEREFROM, now U.S. Pat. No. 10,166,026.

Applicant of the present application also owns the following patentapplications that were filed on Dec. 23, 2013 and which are eachincorporated by reference herein in their respective entireties:

U.S. patent application Ser. No. 14/138,554, entitled SURGICALINSTRUMENTS WITH ARTICULATABLE SHAFT ARRANGEMENTS, now U.S. PatentApplication Publication No. 2015/0173789;

U.S. patent application Ser. No. 14/138,465, entitled SURGICAL STAPLESAND STAPLE CARTRIDGES, now U.S. Patent Application Publication No.2015/0173744;

U.S. patent application Ser. No. 14/138,474, entitled ARTICULATABLESURGICAL INSTRUMENTS WITH SEPARATE AND DISTINCT CLOSING AND FIRINGSYSTEMS, now U.S. Pat. No. 9,681,870;

U.S. patent application Ser. No. 14/138,485 entitled SURGICAL CUTTINGAND STAPLING INSTRUMENTS WITH INDEPENDENT JAW CONTROL FEATURES, now U.S.Pat. No. 9,839,428;

U.S. patent application Ser. No. 14/138,475, entitled SURGICAL STAPLESAND STAPLE CARTRIDGES, now U.S. Patent Application Publication No.2015/0173749;

U.S. patent application Ser. No. 14/138,481, entitled SURGICAL STAPLESAND METHODS FOR MAKING THE SAME, now U.S. Pat. No. 9,968,354;

U.S. patent application Ser. No. 14/138,489 entitled SURGICAL STAPLES,STAPLE CARTRIDGES AND SURGICAL END EFFECTORS, now U.S. Pat. No.9,687,232;

U.S. Design Patent Application Serial No. 29/477,488, entitled SURGICALFASTENER, now U.S. Design Patent No. D775,336;

U.S. patent application Ser. No. 14/138,505 entitled FASTENER CARTRIDGECOMPRISING AN EXTENDABLE FIRING MEMBER, now U.S. Pat. No. 9,585,662;

U.S. patent application Ser. No. 14/138,518 entitled FASTENER CARTRIDGECOMPRISING A FIRING MEMBER CONFIGURED TO DIRECTLY ENGAGE AND EJECTFASTENERS FROM THE FASTENER CARTRIDGE, now U.S. Pat. No. 9,763,662;

U.S. patent application Ser. No. 14/138,530 entitled FASTENER CARTRIDGECOMPRISING A FIRING MEMBER INCLUDING FASTENER TRANSFER SURFACES, nowU.S. Pat. No. 9,549,735;

U.S. patent application Ser. No. 14/138,507, entitled MODULAR SURGICALINSTRUMENTS, now U.S. Pat. No. 9,724,092;

U.S. patent application Ser. No. 14/138,497, entitled SURGICAL CUTTINGAND STAPLING INSTRUMENTS WITH ARTICULATABLE END EFFECTORS, now U.S. Pat.No. 9,642,620; and

U.S. patent application Ser. No. 14/138,516, entitled SURGICAL CUTTINGAND STAPLING METHODS, now U.S. Patent Application Publication No.2015/0173756.

Numerous specific details are set forth to provide a thoroughunderstanding of the overall structure, function, manufacture, and useof the embodiments as described in the specification and illustrated inthe accompanying drawings. Well-known operations, components, andelements have not been described in detail so as not to obscure theembodiments described in the specification. The reader will understandthat the embodiments described and illustrated herein are non-limitingexamples, and thus it can be appreciated that the specific structuraland functional details disclosed herein may be representative andillustrative. Variations and changes thereto may be made withoutdeparting from the scope of the claims.

The terms “comprise” (and any form of comprise, such as “comprises” and“comprising”), “have” (and any form of have, such as “has” and“having”), “include” (and any form of include, such as “includes” and“including”) and “contain” (and any form of contain, such as “contains”and “containing”) are open-ended linking verbs. As a result, a surgicalsystem, device, or apparatus that “comprises,” “has,” “includes” or“contains” one or more elements possesses those one or more elements,but is not limited to possessing only those one or more elements.Likewise, an element of a system, device, or apparatus that “comprises,”“has,” “includes” or “contains” one or more features possesses those oneor more features, but is not limited to possessing only those one ormore features.

The terms “proximal” and “distal” are used herein with reference to aclinician manipulating the handle portion of the surgical instrument.The term “proximal” referring to the portion closest to the clinicianand the term “distal” referring to the portion located away from theclinician. It will be further appreciated that, for convenience andclarity, spatial terms such as “vertical”, “horizontal”, “up”, and“down” may be used herein with respect to the drawings. However,surgical instruments are used in many orientations and positions, andthese terms are not intended to be limiting and/or absolute.

Various exemplary devices and methods are provided for performinglaparoscopic and minimally invasive surgical procedures. However, thereader will readily appreciate that the various methods and devicesdisclosed herein can be used in numerous surgical procedures andapplications including, for example, in connection with open surgicalprocedures. As the present Detailed Description proceeds, the readerwill further appreciate that the various instruments disclosed hereincan be inserted into a body in any way, such as through a naturalorifice, through an incision or puncture hole formed in tissue, etc. Theworking portions or end effector portions of the instruments can beinserted directly into a patient's body or can be inserted through anaccess device that has a working channel through which the end effectorand elongated shaft of a surgical instrument can be advanced.

A staple, or fastener, disclosed herein is configured for use with asurgical stapling instrument. Discussed in greater detail below, thestaple is removably stored in a staple cavity of a staple cartridge. Thestaple cartridge comprises a sled configured to receive a firingactuation from the surgical stapling instrument which imparts a force onthe staple to eject the staple from the staple cavity. When the stapleis ejected, or driven, out of the staple cavity by the sled, the stapleundergoes a deformation process where the staple forms into a firedconfiguration from an unfired configuration. The staple forms into thefired configuration when the staple contacts corresponding formingpockets of an anvil of the surgical stapling instrument.

Various staples disclosed herein comprise a flat-formed staple which canbe cut and/or stamped from a sheet of material, for example. The sheetof material can be metallic and can comprise stainless steel and/ortitanium, for example. In at least one instance, outlines can be traced,etched, and/or cut into the sheet of material which are machined and/orlaser cut to form the staples into a manufactured shape.

The staples comprise a pair of staple legs and a staple base portion, orcrown, from which the staple legs extend. Each staple leg comprises astaple tip, or piercing portion, which is configured to pierce thetissue and contact a corresponding forming pocket of the anvil of thesurgical stapling instrument. The staple legs are configured to changeshape to achieve a formed configuration to fasten the tissue. The staplebase portion defines a first plane and the staple legs define a secondplane which is laterally offset from but at least substantially parallelto the first plane. Embodiments are envisioned where the first andsecond planes are not parallel.

The flat-formed staple 100 depicted in FIGS. 1-4 comprises a proximalstaple leg 110, a distal staple leg 120, and a staple base portion 130.The staple 100 further comprises vertical transition portions, or bends,118, 128 and lateral transition portions, or bends, 116, 126. Thevertical transition portions 118, 128 bend, or extend, the legs 110, 120vertically, or upward, from the staple base portion 130. The lateraltransition portions 116, 126 extend the staple legs 110, 120 laterallyoutward, or at least substantially perpendicularly with respect to thestaple base portion 130. The staple legs 110, 120 define a first planeand the staple base portion 130 defines a second plane. Together, thevertical transition portions 118, 128 and the lateral transitionportions 116, 126 permit the staple legs 110, 120 to be laterally offsetand parallel with respect to the staple base portion 130. Stated anotherway, the first plane is offset from and at least substantially parallelto the second plane. In FIGS. 1-4, the first plane is offset in thenegative Y direction. Other staples may be used in conjunction with aplurality of staples 100 where the other staples comprise a first planewhich is offset in the positive Y direction. The use of both types ofstaples permits staple rows to be nested, or interwoven, where staplelegs of neighboring rows may be at least substantially aligned and/orshare a common longitudinal axis. In various instances, the staple rowscan be nested to provide denser staple rows.

The proximal staple leg 110 and the distal staple leg 120 comprisestaple tips 112, 122 and corners 114, 124, respectively. The tips 112,122 are configured to pierce tissue and contact a forming pocket of ananvil of a surgical stapling instrument. The tips 112, 122 contact theanvil when the staple 100 receives a driving force to eject the staple100 from a corresponding staple cavity in the staple cartridge. The tips112, 122 and/or legs 110, 120 of the staple 100 will then begin formingfrom an unfired configuration to a fired configuration. The proximalstaple leg 120 further comprises a leading engagement foot 117comprising a chamfered surface, or edge, 119. As the sled contacts thestaple 100 upon the sled's distal translation, a feature of the sled canengage the leading engagement foot 117 to aid in preventing longitudinalstaple roll, or rotation, for example. The engagement foot 117 cancomprise a push point that is configured to be pushed on to load thestaple 100 into a staple cartridge.

Since the staple 100 is a flat-formed staple, the staple legs 110, 120,tips 112, 122, and/or other portions of the staple 100 can be furtherdeveloped, or worked, after being stamped from a flat, or at leastsubstantially flat, stock. Further developing the staple 100 can providespecific properties creating and/or altering preferential bendingplanes, toughness, and/or elasticity, for example. Traditionalwire-formed staples comprise desirable properties advantageous forsurgical fastening and can be implemented with the staple 100. Methodsfor constructing the corners 114, 124 and/or tips 112, 122, for example,may include any suitable process including cold working, for example. Aspecific process may include coining by working the corners 114, 124into a rounded, angled, oblique, and/or parabolic profile, for example.The staple tips 112, 122 can also be worked using similar methods toprovide an adequate tip configured to pierce tissue and form against acorresponding forming pocket of the anvil.

The staple base portion 130 comprises an inclined drive surface 132, afinal drive surface 131, and a distal wall 133. In various embodiments,the staple 100 is supported in a staple cartridge by a pan where thefinal drive surface 131 is configured to rest on the pan. In variousother embodiments where a staple cartridge is pan-less, the final drivesurface does not rest on a pan, rather, the final drive surfacecomprises an initial position residing above a bottom surface of thepan-less staple cartridge. This would allow a bottom surface of the sledand the bottom surface of the pan-less staple cartridge to be at leastsubstantially flush as the sled translates through the cartridge. Thedrive surface 132 of each staple base portion 130 is configured toreceive the driving force F_(s) from the sled of the surgical staplinginstrument. When the sled translates distally through the staplecartridge, the sled contacts the drive surface 132 to lift the staple100 out of the cartridge and, in addition, contact the final drivesurface 131 to form the staple 100 into its fired configuration.

The distal wall 133 acts as a distal-most wall of the staple baseportion 130 and is positioned proximal of the distal staple leg 120resulting in a lack of any portion of the staple base portion 130underneath the distal staple leg 120. Having a greater amount of mass inthe base portion 130 of the staple 100 increases the ability of thestaple 100 to resist rotational motion caused by the moment M_(S)applied by the sled. Increasing the moment of inertia of the staple baseportion 130 increases the ability to resist rotational motion. As aresult, a greater torque, or larger moment, would be required to causelongitudinal staple roll.

The staple base portion 130 further comprises a top surface, orcompression surface, 136 comprising a proximal surface 139, anintermediate surface 138, and a distal surface 137. The proximal surface139 is angled, or slanted, upward toward the proximal leg 110. Thedistal surface 137 is angled, or slanted, upward toward the distal leg120. The intermediate surface 138 is at least substantially parallel tothe final drive surface 131. This valley-like configuration limits thestress concentration of tissue captured near the transition portions118, 128, 116, 126 where the legs 110, 120 extend from the staple baseportion 130. In various embodiments, these surfaces 137, 138, 139 can becurved to create a concave surface. In traditional staples, when formed,the connections where the legs meet the staple base produce locationsresponsible for highly localized tissue stress. This is especially truein the event that such a traditional staple buckles, or is crushed, orflattened, rather than formed into a true “B” configuration.

In various embodiments, the dynamics of the staple 100 are predictablewhen ejected from a staple cartridge. As the staple 100 is ejected fromits corresponding staple cavity, a driving force F_(S) from the sledgenerates a moment M_(s). One preventive measure for preventing stapleroll includes increasing the moment of inertia of the staple 100,discussed above, which is configured to prevent, as illustrated in FIG.2, longitudinal roll, or rotation of the staple. In the event that thestaple 100 rolls longitudinally in the distal direction, or, in otherwords, rotates counterclockwise about the Y axis, outer, longitudinalstaple leg surfaces 115, 125 of the staple 100 will contact the guidesurfaces, or sidewalls, of the staple cartridge. This contact producescorresponding reaction forces F_(C1) and F_(C2). More particularly, asthe staple 100 is driven out of the staple cavity and rotated about theY axis, the wall 115 of the proximal staple leg 110 contacts a proximalsidewall of the staple cartridge producing a reaction force F_(c2) whichacts upon the staple leg 110 below the center of mass. The wall 125 ofthe distal staple leg 120 contacts a distal sidewall of the staplecartridge producing a reaction force F_(C1) which acts upon the stapleleg 120 above the center of mass. Both reaction forces, F_(C1) andF_(C2), contribute to a reactional moment M_(RC) to counteract, orbalance, the applied moment M_(S) acting on the staple 100. The reactionforces discussed herein may be distributed loads acting upon a surfacearea of each of the staple legs 110, 120.

The moment of inertia of the staple 100 is also configured to prevent,as illustrated in FIG. 4, lateral roll, or rotation of the staple 100.The staple base portion 130 comprises a notch 134 defined in the topsurface 136 on a side of the staple base portion 130 closest to the legs110, 120. The notch 134 contributes to the predictability of thedynamics of the staple 100 before formation and upon formation whenejected from the staple cartridge. For example, referring primarily toFIG. 4, the notch 134 is configured to induce rotation of the staple 100toward a particular cavity sidewall. In the event that the staple 100rolls laterally, or, in other words, rotates in the direction of theapplied moment M_(S), outer, lateral staple leg walls 111, 121 of thestaple 100 will contact the guide surfaces, or sidewalls, of the staplecartridge producing corresponding reaction forces F_(C1) and F_(C2). Forexample, as the staple 100 is driven out of the staple cavity androtated in the direction of the applied moment M_(S), the walls 111, 121of the staple legs 110, 120 contact a corresponding sidewall of thestaple cartridge producing a reaction force F_(C1) which act upon thestaple legs 110, 120 above the center of mass. An outer lateral wall 135of the staple base portion 130 contacts another corresponding sidewallof the staple cartridge producing a reaction force F_(C2) which actsupon the staple base portion 130 below the center of mass. Reactionforces F_(C1) and F_(C2) produce a reactional moment M_(RC) tocounteract, or balance, the applied moment M_(S) acting on the staple100 from the sled. The reaction forces discussed herein may bedistributed loads acting upon a surface area of each of the staple legs110, 120 and the staple base portion 130. In various embodiments, thestaple 100 is encouraged to roll laterally in the direction of theapplied moment M_(S) to control which walls of the staple cavity aregoing to be contacted for staple guidance as the staple 100 is ejectedfrom the staple's 100 corresponding staple cavity.

FIGS. 5 and 6 illustrate a wire-formed staple 200 comprising staple legs210 and a staple base portion 230. The staple legs 210 are offset andbent at a substantially ninety degree angle from the staple base portion230. The staple legs 210 reside in a first plane which is at leastsubstantially perpendicular to a second plane defined by the staple baseportion 230 and the bend portions 220 of the staple legs 210.

FIGS. 7-10 illustrate a staple 300 comprising a proximal staple leg 310,a distal staple leg 320, and a staple base portion, or crown, 330 havinga drive surface 332. The staple legs 310, 320 extend from the staplebase portion 330 and each staple leg 310, 320 comprises a laterallyoutward bend portion and an upward bend portion. The laterally outwardbend portions of the staple legs bend the staple legs laterally outwardwith respect to the staple base portion. The upward bend portions of thestaple legs bend the staple legs vertically with respect to the staplebase portion. The staple 300 comprises a first zone 331 comprising afirst hardness, second zones 311, 321 comprising a second hardness, andthird zones 312, 322 comprising a third hardness. Embodiments areenvisioned where the staple 300 comprises more or less zones thandepicted. Varying certain properties, such as the hardness, of differentportions of the staple 300 can provide greater control andpredictability when forming the staple against corresponding formingpockets such as forming pockets 341 of anvil 340, for example. The firsthardness of the first zone 331 may be greater than that of the secondhardness of the second zones 311, 321. In many instances, it isdesirable to have ductile staple legs 310, 320 capable of permanentlychanging shape without fracture or, in other words, having staple legs310, 320 with a high plasticity, while having a staple base portion 330that supports the staple legs 310, 320 and comprises a hardness greaterthan the staple legs 310, 320, for example. A greater hardness wouldincrease the staple base portion's 330 ability to resist deformationupon the application of an external and/or internal force, such as aforce from the staple legs upon being compressed against the anvil, forexample.

Metal working different portions of the staples disclosed herein cancomprise several advantages. One of these advantages may include beingable to prevent crushing, or buckling, of the staple legs duringformation and, instead, encourage the staple legs to deform in a desiredconfiguration as a result of the contact with the corresponding formingpockets.

The staple 300 may be formed into any desired formation. In an unformedconfiguration, the staple legs 310, 320 define a first plane P₁ and thestaple base portion 330 defines a second plane P₂. Shown in FIGS. 9 and10 is an example of a formation of the staple 300 in which the staplelegs 310, 320 are formed laterally toward the second plane P₂.Variations in hardness of certain zones and/or portions of the staple300 can be responsible for providing directional encouragement whencontacting the forming pockets 341. Embodiments are envisioned where thestaple legs 310, 320 are formed in a direction laterally away from thesecond plane P₂.

FIGS. 11-11C depict a staple 400 comprising staple legs 410 and a staplebase portion 430 formed from a flat sheet of material. The staple baseportion 430 comprises a rectangular cross-sectional profile 431 and thestaple legs comprise a round cross-sectional profile 411. Having roundstaple legs 410 that extend from a staple base portion 430 having therectangular cross-sectional profile 431 can provide a staple baseportion and staple legs with no preferential bending planes. The staple400 comprises bend portions 420 where the staple legs 410 extend fromthe staple base portion 430. The bend portions 420 comprise asubstantially square cross-sectional profile 421. The square profile 421and the rectangular profile 431 of the bend portions 420 and the staplebase portion 430, respectively, provide a stiff connection and backboneto the round staple legs 410. The round staple legs 410 eliminatepreferential bending planes that staple legs with a square, rectangular,or any shape with vertices or a non-uniform shape, cross-sections couldhave.

FIG. 12 depicts a staple 500 in accordance with at least one embodimentcomprising a proximal staple leg 510, a distal staple leg 520, and astaple base portion 530 from which the staple legs 510, 520 extend. Theproximal staple leg 510 is bent laterally outward from the staple baseportion 530 in a first direction. The distal staple leg 520 is bentlaterally outward from the staple base portion in a second direction.The first direction is opposite the second direction. The staple baseportion 530 defines a first plane and the staple legs 510, 520 define asecond plane which intersects the first plane. One advantage of havingthe staple legs 510, 520 bent in opposite directions can help preventlateral roll by counteracting the applied sled moment on each side ofthe staple base portion 530. This results in an S-shaped configurationand requires complimentary forming pockets.

A staple 600 is depicted in FIG. 13 comprising a proximal leg 610, adistal leg 620, and a staple base portion 630 having a drive surface632. The distal leg 620 is longer than the proximal leg 610 resulting inan offset contact timing of the tips 611, 621 of the staple legs 610,620 against the forming pockets of the anvil. In various embodiments,the distal leg may comprise a tip that comprises an initial pre-bentconfiguration to aid in the forming process when initially contactingthe anvil. This pre-formed tip 621 would require less compressive forcethan the staple tip 611 to begin deformation against the anvil. Havingthe longer staple leg, in this case the distal staple leg 620, contactthe anvil before the shorter, or proximal, staple leg, 610 may requirethe staple tip 621 of the longer leg 620 to have, to a certain degree, apre-formed tip before the tip 611 is deformed.

FIG. 14 illustrates an arrangement 700 of formed staples 711, 721. Thestaples 711 are arranged in a first row 710 and the staples 721 arearranged in a second row 720 which is adjacent to the first row 710. Thestaples 711, 712 may be similar to that of the staple 600 illustrated inFIG. 13 discussed above. The staples 711 comprise laterally opposinglegs 713, 715. The staples 721 comprise laterally opposing legs 723,725. The laterally opposing legs 713, 715 each comprise tips configuredto contact forming pockets of an anvil at contact points 713 c, 715 c,respectively. The laterally opposing legs 723, 725 also each comprisetips configured to contact forming pockets of an anvil at contact points723 c, 725 c, respectively. The laterally opposing legs 713, 715 eachform inwardly toward the staple base portion from which they extend. Thelaterally opposing legs 723, 725 also each form inwardly toward thestaple base portion from which they extend.

The staple rows 710, 720 are interwoven such that the contact points 723c, 713 c are in substantial alignment. Such an arrangement allows for amore densely arranged staple row configuration in a staple cartridgeand/or a more densely arranged forming pocket configuration on an anvil.Also, intersecting purchase planes may provide for a higher qualitypurchase and a larger area of purchase coverage in the tissue. Theintersecting purchase planes may guarantee that anything capturedbetween the staple rows and the forming pockets is guaranteed to beadequately fastened. This can help when stapling smaller vessels and/ornot easily visible vessels that, in conventional staple arrangements,may navigate staple row separations resulting in less than adequatefastening.

FIGS. 15-17 depict a staple 800 comprising staple legs 810, 820 and astaple base portion 830 having a drive surface 832. The staple legs 810,820 comprise tips 842 configured to contact forming pockets of an anvil,such as forming pocket 861 of the anvil 860, for example. The stapletips 842 comprise a piercing tip, or portion, 842T, a curling surface842S, and a concave cutout portion 842C. The piercing tip 842T isconfigured to pierce the tissue T upon ejection from the staplecartridge and, once in contact with the forming pocket 861 of the anvil860, deform within the forming pocket 861. Deformation of the staple tip842 is encouraged into a certain formation by utilizing the predictabledeformability of the concave cutout portion 842C. The curling surface842S of the staple tip 842 is configured to curl, or deform, from apiercing position 812A, to an intermediate formed position 812B, and toa non-piercing position 812C. Once the staple tip 842 has deformedcompletely, the piercing tip 842T is shielded, or isolated, from thetissue T by the curling surface 842S. This prevents further piercing ofthe tissue T after the tip 842 pierces the tissue upon ejection. Thisarrangement also prevents further injury and/or unwanted irritation thata piercing tip that is exposed after the initial piercing could possiblyinflict. Preventing further piercing of the tissue T after the legs areformed also lessens the chance of the staple 800 being pulled throughthe tissue T. The curling surface 842S acts as a shield configured toshield the piercing tip 842T from the tissue T.

FIG. 18 depicts multiple examples of different types of staple tips 871,872, 873, 874, and 875 that can be employed with any suitable surgicalstaple such as the staples disclosed herein. Staple tip 871 comprises atriangular shape with an at least substantially flat face. Staple tip872 comprises a face with a varying contour. Staple tip 873 comprises arocket-like shape. Staple tip 874 comprises a nub-like profile. Thenub-like profile may be substantially dull, for example. Staple tip 875comprises a pencil-sharpened profile.

In various embodiments, the staple tips disclosed herein may comprise amaterial different than that of the staple to which the staple tip isconnected in order to make deforming in the fashion desired easier,however, the staple tip material can still be strong enough to preventunfolding of the staple tip after fastening tissue.

Surgical staples can be encouraged to form into a desired configurationby changing the shape, size, configuration, and/or other aspects of theforming pockets configured to form the staples. FIG. 19 depicts formingpockets 911, 921 configured to form a staple 900. The staple 900comprises staple legs 901, 902, staple tips 910, 920, and a staple base930, wherein the staples legs 901, 902 extend from the staple base 930.The staple 900 is configured to contact and form against thecorresponding forming pockets 911, 921. The forming pocket 911 comprisesa forming channel surface 917 configured to receive a corresponding tip910 and encourage the tip 910 to form in a direction P1. Shown in FIG.20, the forming pocket 911 comprises lateral valley-like surfaces 915and longitudinal valley-like surfaces 913 configured to funnel, orcatch, the tip 910 of the staple in the event of minor misalignment uponcontact. The staple 900, staple leg 901, and/or staple tip 910 may bedriven off target with respect to the forming channel surface 917 uponejection from the cartridge. The valley-like surfaces permitlongitudinal and lateral roll of the staple. Although illustrated asconcave surfaces, the valley surfaces may be convex or flat, forexample.

The forming pocket 921 comprises a forming channel surface 927configured to receive a corresponding tip 920 of the staple 900 andencourage the tip 920 to form in a direction D1. The direction D1 isopposite the direction P1 and, as shown in FIG. 19, illustrates aninstance in which the staple legs are formed toward each other and atleast substantially parallel to the staple base 930. Other embodimentsare envisioned where the directions D1, P1 direct the correspondingstaple legs in opposite directions but outward with respect to eachother. The forming pocket 921 further comprises lateral valley-likesurfaces 925 and longitudinal valley like surfaces 923 configured tofunnel, or catch, the tip 920 of the staple 900 in the event of minormisalignment upon contact. The staple 900, staple leg 902, and/or stapletip 920 may be driven off target with respect to the forming channelsurface 927 upon ejection from the cartridge.

In various embodiments, the longitudinal valley-like surfaces maycomprise two separate valley surfaces. The two separate valley surfacesmay comprise an initial valley surface nearest the intended point ofcontact for the corresponding staple tip. The initial valley surface maycomprise a larger range of misalignment protection than the other of theseparate valley surfaces. The initial valley surface may comprise alarger width and/or height than the other of the separate valleysurfaces, for example.

FIG. 21 depicts another arrangement of the staple pockets 911, 921discussed above. However, the staple pockets 911, 921 in the illustratedarrangement are configured to direct the staple tips inward toward thestaple base 130. The leg 901 and tip 910 are configured to be formed indirection P2. The leg 902 and tip 920 are configured to be formed indirection D2. The directions P2, D2 are transverse. Other embodimentsare envisioned where the directions P2, D2 direct the correspondingstaple legs and tips away from the staple base, or outward.

FIG. 22 depicts yet another arrangement of the staple pockets 911, 921discussed above. The staple pockets 911, 921 in the illustratedarrangement are configured to form the corresponding staple legs 901,902 and tips 910, 920 in opposite directions where one of the staplelegs 902 is directed toward the staple base 930 and one of the staplelegs 901 is directed away from the staple base 930. The leg 901 and tip910 are configured to form in direction P3. The leg 902 and tip 920 areconfigured to form in direction D3. The directions P3, D3 are at leastsubstantially parallel. Other embodiments are envisioned where thedirections P3, D3 are not parallel.

FIGS. 23 and 24 depict another embodiment of forming pockets comprisingforming pockets 1011, 1021 configured to deform the staple 900. Theforming pockets 1011, 1021 comprise an ear-like shape providing nestedpockets. This type of arrangement can save space on the staple formingsurface of an anvil to allow for more staple pockets and, as a result,more staples in a staple cartridge in a lesser amount of space. Theforming pocket 1011 comprises a forming channel surface 1017 configuredto receive the corresponding tip 910 and encourage the tip 910 to formin a curved direction P4. Shown in FIG. 24, the forming pocket 1011comprises a first valley-like, curved surface 1015A and a secondvalley-like, curved surface 1015B configured to funnel, or catch, thetip 910 of the staple in the event of minor misalignment during contact.The staple 900, staple leg 901, and/or staple tip 910 may be driven offtarget with respect to the forming channel surface 917 upon ejectionfrom its staple cavity. The valley-like surfaces permit somelongitudinal and lateral roll of the staple. Although illustrated asconcave surfaces, the valley surfaces may be convex or flat, forexample.

The forming pocket 1021 comprises a forming channel surface 1027configured to receive the corresponding tip 920 of the staple 900 andencourage the tip 920 to form in a direction D4. FIG. 23 illustrates aninstance in which the staple legs 901, 902 are formed toward each otherwith one staple leg 901 formed away from the staple base 930 and onestaple leg 902 formed toward the staple base 930. Other embodiments areenvisioned where the directions P4, D4 direct the corresponding staplelegs 901, 902 in opposite directions but outward with respect to eachother. The forming pocket 1021 comprises a first valley-like, curvedsurface 1025A and a second valley-like, curved surface 1025B configuredto funnel, or catch, the tip 920 of the staple 900 in the event of minormisalignment before and/or during contact.

FIG. 25 depicts yet another embodiment of forming pockets comprisinganvil forming pockets 1111, 1121 configured to deform correspondingstaple legs 901, 902 and tips 910, 920 toward the staple base 930. Theforming pockets 1111, 1121 are trapezoidal in shape and can be nestedwith other similar forming pockets using less space on a forming surfaceof an anvil. The forming pockets 1111, 1121 are configured to form thestaple legs 901, 902 and tips 910, 920 in directions P5, D5,respectively.

FIG. 26 depicts yet another embodiment of forming pockets comprisinganvil forming pockets 1211, 1221 configured to deform correspondingstaple legs 901, 902 and tips 910, 920 in directions P6, D6,respectively. The forming pockets 1111, 1121 are triangular in shape andcan be nested with each other comprising an even more compact formingpocket arrangement on an anvil of a surgical stapling instrument.

Referring now to FIGS. 27-27B, a staple leg 1300 is depicted. The stapleleg 1300 comprises a substantially round staple tip with a substantiallysquare staple leg and a staple leg body portion 1301. The staple leg1300 comprises hardened corners formed using a coining process, forexample, where the corners 1303A, 1303B, 1303C, and 1303D were roundedin order to create preferential bending planes. Stated another way, thestaple leg 1300 comprises a cross-sectional profile configured toencourage the staple leg 1300 to bend in a certain direction due to thecorner hardening upon contact with an anvil. The corners 1303A, 1303B,1303C, and 1303D may vary in hardness from one corner to the next, or,may comprise two corners with a first hardness and the other two cornerswith a second hardness. The corners 1303A, 1303B, 1303C, and 1303D maybe coined to provide different radial profiles on the same staple leg.For example, the corner 1303A comprises a radial profile with a radiusR_(A) greater than the radius R_(B) of the radial profile of corner1303B shown in FIG. 27B.

Portions of the staples disclosed herein may be hardened at varioustimes of the manufacturing process with any suitable means. For example,hardening process may include bronzing, chemical vapor deposition,physical vapor deposition, laser surface treatment, thermal oxidation,ion nitriding, and/or solid state diffusion, for example. Other portionsof the staples may be prevented from being hardened by these processes.Other portions of the staples may be locally annealed, such as thestaple tips, for example. Increasing hardness in certain areas canincrease the force required to unform the staples after the staples haveassumed a fired configuration.

FIGS. 28-28C depict a staple 1400 and a sled 1460 in accordance with atleast one embodiment. The staple 1400 comprises staple legs 1410, 1420,a staple base portion 1430 from which the staple legs 1410, 1420 extend,a drive surface 1432, and a bottom surface 1431. The staple legs 1410,1420 extend from the staple base portion 1430 in a plane which is aparallel and offset with respect to a plane defined by the staple baseportion 1430. The staple 1400 is made with progressive die stampingutilizing a base strip 1450 and a connector portion 1451. Although onlya single staple 1400 is shown, a plurality of staples 1400 are attachedto the base strip 1450. The connector portion 1451 connects the staple1400, specifically the staple base portion 1430, to the base strip 1450.The connector portion 1451 comprises a discontinuity, or notch, 1453configured to permit the staples 1400 to detach from the strip 1450. Inat least one instance, the sled 1460 comprises release portions, orstriking portions, 1461. The release portions 1461 of the sled 1460 areconfigured to engage the discontinuities 1453, or connector portions1451, to separate, break, and/or shear, the staples 1400 from the basestrip 1450 and permit the staples to be ejected from their staplecavities by the sled 1460.

Embodiments are envisioned where the base strip 1450 comprises alignmentfeatures such as holes, for example, which engage correspondingalignment features on a staple cartridge. Such alignment features maycomprise protrusions, for example, that align with the alignmentfeatures of the base strip 1450. In various instances, a person loadingthe staples into the cartridge could align the staples with the staplecavities and/or align the alignment features before pushing the staplesinto the staple cavities. Certain embodiments are envisioned in whichthe staple cartridge comprises engagement features configured to engagethe discontinuities 1453 when the strip assemblies are loaded into thestaple cartridge. The engagement features allow the staples 1400 to beseparated from the strip 1450 when the staples 1400 are loaded into astaple cartridge instead of when the staples 1400 are fired.Manufacturing staples using progressive die stamping can permit staplesto have different crown sizes, shapes, and/or configurations as well asstaple leg sizes, shapes, and/or configurations. Another advantage ofusing progressive die stamping technology may include the ability toalter the spacing of the rows of staples in which the staples arealigned.

FIGS. 29 and 30 depict another embodiment of a strip 1500 of staples1501 made with progressive die stamping. The strip 1500 of staples 1501comprises a base strip 1550, a connector portion 1551, and staples 1501.Each staple 1501 comprises, one, a staple base portion 1530 comprising abottom surface 1531 and, two, staple legs 1510 extending from the staplebase portion 1530. The connector portion 1551 attaches the bottomsurface 1531 of the staple base portion 1530 to the base strip 1550. Thestaple legs are bent up from the staple base portion 1530 such that thelegs 1510 reside in a plane which is offset and at least substantiallyparallel to a plane defined by the staple base portion 1530. In theillustrated embodiment, the staple legs 1510 are bent in a directionopposite to that of the connector portion 1551. Bending the legs 1510and the connector portions 1551 in this manner can permit a more densestaple row arrangement. The connector portions 1551 can comprise adiscontinuity enabling the staples 1501 to be released from the basestrip 1550 upon loading the staples 1501 into a staple cartridge and/orfiring the staples 1501 from the staple cartridge as discussed in theprevious embodiment.

FIG. 31 depicts a plurality of staples 1601 and a cross-sectional viewof a portion of a staple cartridge 1650 in accordance with at least oneembodiment. The staples 1601 are removably stored within correspondingstaple cavities 1651 of the staple cartridge 1650. The staple cartridge1650 comprises a deck surface 1653 and staple leg supports 1655. Thestaples 1601 comprise, one, staple legs 1610 which each comprise astaple tip 1611 and, two, a staple base portion 1630 from which thestaple legs 1610 extend. Each staple 1601 comprises a pre-loadconfiguration, a loaded configuration, and a fired configuration wherethe staple 1601 is ejected from the staple cartridge 1650 and formedagainst corresponding forming pockets of an anvil. The staple legs 1610are bent outwardly with respect to the staple base portions 1630 in thepre-load configuration. The staple legs 1610 are biased againstsidewalls of the corresponding staple cavity 1651 in the loadedconfiguration and define a first distance X between the tips 1611 of thestaple legs 1610. In the pre-load configuration, the distance betweenthe staple tips 1611 of the staple legs 1610 is greater than X. Thisbiasing force helps support the staples 1601 in the staple cartridge1650.

A staple cartridge 2000 is illustrated in FIGS. 32-34. The staplecartridge assembly 2000 comprises a cartridge body 2010. The cartridgebody 2010 is positionable in and removable from a jaw of a surgicalstapling instrument. As a result, the staple cartridge 2000 isreplaceable; however, other embodiments are envisioned in which thestaple cartridge 2000 is not replaceable. The cartridge body 2010comprises a proximal end 2011, a distal end 2012, and a deck 2014extending between the proximal end 2011 and the distal end 2012. Thedeck 2014 is configured to support the tissue of a patient when thetissue is compressed against the deck 2014.

The cartridge body 2010 further comprises a plurality of staple cavities2020 defined therein. The staple cavities 2020 are arranged in sixlongitudinal rows extending between the proximal end 2011 and the distalend 2012; however, any suitable arrangement of staple cavities 2020 canbe utilized. A staple, such as staple 2130 (FIG. 40), for example, isremovably stored in each staple cavity 2020. As discussed in greaterdetail below, the staples are ejected from the staple cavities 2020 by afiring member when the firing member is moved from the proximal end 2011of the cartridge body 2010 toward the distal end 2012.

Further to the above, the staples are moved from an unfired position toa fired position by the firing member. The firing member lifts thestaples toward an anvil, such as anvil 2190 (FIG. 37), for example, todeform the staples between an unfired, undeformed configuration and afired, deformed configuration. The cartridge body 2010 further comprisesa longitudinal slot 2013 defined therein. The slot 2013 is configured toreceive the staple firing member and/or a tissue cutting member thereinwhen the staples are ejected from the staple cavities 2020.

In various embodiments, further to the above, the staples do notprotrude above the deck 2014 until they are moved toward the anvil bythe firing member. Such embodiments may frequently utilize smallstaples. In other embodiments, the legs of the staples protrude abovethe deck 2014 when the staples are in their unfired positions. In atleast one such embodiment, the cartridge body 2010 further comprisesprojections 2050 extending from the deck 2014. The projections 2050extend the staple cavities 2020 above the deck 2014 and guide thestaples toward the anvil when the staples are being ejected from thestaple cartridge 2000. In such embodiments, the staples may not extendabove the projections 2050 until they are moved toward the anvil by thefiring member.

Referring primarily to FIG. 34, the projections 2050 do not extendaround the entirety of the staple cavities 2020. A first projection 2050is positioned adjacent a first end of each cavity 2020 and a secondprojection 2050 is positioned adjacent a second end of each cavity 2020.Each first projection 2050 extends around a first staple leg guide 2022of a staple cavity 2020 and each second projection 2050 extends around asecond staple leg guide 2023 of the staple cavity 2020. Each firstprojection 2050 provides a proximal bracket which can control and guidethe proximal leg of a staple and each second projection 2050 provides adistal bracket which can control and guide the distal leg of the staple.The first projection 2050 of each staple cavity 2020 is not symmetricalwith respect to the first end of the staple cavity 2020 and does notextend around the entirety of the first end of the cavity 2020.Similarly, the second projection 2050 of each staple cavity 2020 is notsymmetrical with respect to the second end of the staple cavity 2020 anddoes not extend around the entirety of the second end of the cavity2020. The first projection 2050 and the second projection 2050 comprisemirror images of one another and are symmetrically arranged with respectto the center of each staple cavity 2020; however, any suitablearrangement of projections could be utilized.

As illustrated in FIGS. 32-34, the cartridge body 2010 comprises steps2014′ and steps 2014″ which extend upwardly from the deck 2014. Morespecifically, the steps 2014′ extend upwardly from the deck 2014 and thesteps 2014″ extend upwardly from the steps 2014′. As a result, the steps2014″ may apply a larger compressive pressure to the tissue than thesteps 2014′ and, similarly, the steps 2014′ may apply a largercompressive pressure to the tissue than the deck 2014. The steps 2014′and 2014″ comprise staggered longitudinal plateaus; however, the steps2014′ and 2014″ may comprise any suitable configuration. Moreover,further to the above, the projections 2050 extending from the steps2014″ extend above the projections 2050 extending from the steps 2014′and, similarly, the projections 2050 extending from the steps 2014′extend above the projections 2050 extending from the deck 2014. Statedanother way, the projections 2050 extending from the deck 2014, thesteps 2014′, and the steps 2014″ are staggered.

A staple cartridge 2100 is illustrated in FIGS. 35-38. The staplecartridge assembly 2100 comprises a cartridge body 2110 and is similarto the staple cartridge assembly 2000 and/or the other staple cartridgesdisclosed herein in many respects. The cartridge body 2110 comprises adeck 2114, a plurality of staple cavities 2120 a, and a plurality ofstaple cavities 2120 b. The staple cavities 2120 a are similar to thestaple cavities 2120 b in many respects. For instance, the staplecavities 2120 a and 2120 b both comprise a central slot 2121 having aproximal end and a distal end, a proximal staple leg guide 2122extending laterally from the proximal end of the central slot 2121, anda distal staple leg guide 2123 extending laterally from the distal endof the central slot 2121. That said, the staple cavities 2120 a and thestaple cavities 2120 b are oriented in different directions. Moreparticularly, the staple leg guides 2122, 2123 of the staple cavities2120 a extend toward the staple cavities 2120 b and, similarly, thestaple leg guides 2122, 2123 of the staple cavities 2120 b extend towardthe staple cavities 2120 a; however, any suitable arrangement can beutilized.

A staple 2130 a is positioned in each staple cavity 2120 a and a staple2130 b is positioned in each staple cavity 2120 b. The staples 2130 aand the staples 2130 b are similar in many respects. For instance, eachstaple 2130 a comprises a base, or crown, 2131, a proximal leg 2132extending from a proximal end of the base 2131, and a distal leg 2133extending from a distal end of the base 2131. That said, the staples2130 a, 2130 b are adapted in a manner to fit within the staple cavities2120 a, 2120 b, respectively. For example, when the staples 2130 a arepositioned in the staple cavities 2120 a and the staples 2130 b arepositioned in the staple cavities 2120 b, the legs 2132, 2133 of thestaples 2130 a extend toward the staples 2130 b and the legs 2132, 2133of the staples 2130 b extend toward the staples 2130 a; however, otherarrangements are possible.

Further to the above, the proximal legs 2132 of the staples 2130 a, 2130b are positioned within the staple leg guides 2122 when the staples 2130a, 2130 b are stored in the staple cavities 2120 a, 2120 b,respectively. Similarly, the distal legs 2133 of the staples 2130 a,2130 b are positioned within the staple leg guides 2123 when the staples2130 a, 2130 b are stored in the staple cavities 2120 a, 2120 b,respectively. Moreover, the bases 2131 of the staples 2130 a, 2130 b arepositioned in the central slots 2121 of the staple cavities 2120 when hestaples 2130 a, 2130 b are stored in the staple cavities 2120 a, 2120 b,respectively. Referring primarily to FIG. 35, the tips of the staplelegs 2132, 2133 extend above the deck 2114 of the cartridge body 2110when the staples 2130 a, 2130 b are in their unfired positions. Thatsaid, the tips of the staple legs 2132 are at least partially surroundedby proximal projections 2152 extending from the deck 2114 and the tipsof the staple legs 2133 are at least partially surrounded by distalprojections 2153 extending from the deck 2114. The proximal projections2152 extend around the proximal staple leg guides 2122, but they do notextend around the proximal ends of the central slots 2121. Similarly,the distal projections 2153 extend around the distal staple leg guides2123, but they do not extend around the distal ends of the central slots2121.

Turning now to FIG. 38, each proximal projection 2152 comprises a firstportion 2154 which extends around a proximal side of the proximal guideslot 2122 and a second portion 2155 which extends around a lateral sideof the proximal guide slot 2122. The proximal projection 2152 does notextend around a distal side of the proximal guide slot 2122; however, itis envisioned that the proximal projection 2152 can extend around thedistal side of the proximal guide slot in alternative embodiments.Similarly, each distal projection 2153 comprises a first portion whichextends around a distal side of the distal guide slot 2123 and a secondportion which extends around a lateral side of the distal guide slot2123. The distal projection 2153 does not extend around a proximal sideof the distal guide slot 2123; however, it is envisioned that the distalprojection 2153 can extend around the proximal side of the distal guideslot in alternative embodiments. In any event, the arrangement depictedin FIG. 38 protects the staple legs 2132, 2133 when the staples 2130 a,2130 b are in their unfired positions and, in addition, guide thestaples 2130 a, 2130 b as the staples are being fired. Such anarrangement also appropriately controls the flow of tissue relative tothe deck 2114 of the cartridge body 2110.

Referring again to FIG. 38, the staple cavities 2120 a and the staples2130 a are sized and configured such that clearance gaps are providedbetween the staples 2130 a and the staple cavities 2120 a. For example,a clearance gap 2156 is present between the proximal leg 2132 of astaple 2130 b and the proximal sidewall of the proximal guide slot 2122and, similarly, a clearance gap 2158 is present between the proximal leg2132 of the staple 2130 b and the distal sidewall of the proximal guideslot 2122. In addition, a clearance gap 2157 is present between thelateral side of the proximal leg 2132 and the lateral sidewall of theproximal guide slot 2122. Similar gaps can be found between the distalleg 2133 and the distal guide slot 2123. Lateral clearance gaps 2126,2127 can also be provided between the base 2131 of the staple 2130 b andthe lateral sides of the central slot 2121. Such clearance gaps may betransient and the staple may contact one or more of the sidewallsnonetheless.

A staple cartridge 2200 is illustrated in FIG. 43. The staple cartridge2200 is similar to the staple cartridges 2000, 2100 and the other staplecartridges disclosed herein in many respects. The staple cartridge 2200comprises a cartridge body 2210 including staple cavities 2220 definedtherein. Each of the staple cavities 2220 has a staple, such as staple2130, for example, removably stored therein. Each staple cavity 2220comprises a first guide slot 2222 configured to guide the leg 2132 ofthe staple 2130, a second guide slot 2223 configured to guide the leg2133 of the staple 2130, and a central slot 2221. The guide slots 2222and 2223 extend laterally from the central slot 2221 and the centralslot 2221 includes an intermediate guide 2225 configured to guide thebase 2131 of the staple 2130. The first guide slot 2222 is sized andconfigured such that the staple leg 2132 is closely received in a cornerof the first guide slot 2222. Similarly, the second guide slot 2223 issized and configured such that the staple leg 2133 is closely receivedin a corner of the second guide slot 2223. The intermediate guide 2225is sized and configured to limit the lateral movement of the staple 2130within the staple cavity 2220. Moreover, the intermediate guide 2225 issized and configured to hold the staple legs 2132 and 2133 in the stapleleg guide slots 2222 and 2223, respectively.

As discussed above, the intermediate guide 2225 is sized and configuredto hold the staple legs 2132 and 2133 against the sidewalls of the guideslots 2222 and 2223, respectively. Such an arrangement creates lateralreaction forces, indicated as force vectors LT in FIG. 43, between thelateral sidewalls of the cavity 2220 and the staple 2130. Such lateralreaction forces generate friction forces between the sidewalls of thecavity 2220 and the staple 2130 when the staple 2130 is ejected from thecavity 2220. It should be understood that friction forces are a functionof the surface area in which they are applied and, as such, theintermediate guide 2225 does not extend along the entire length of thecentral slot 2221. That said, the intermediate guide 2225 has alongitudinal length which is sufficient to control the orientation ofthe staple 2130 within the cavity 2220. Moreover, the intermediate guide2225 has a sufficient vertical length sufficient to control theorientation of the staple 2130 during the firing stroke of the staple2130. In at least one instance, the guide 2225 extends along the entirevertical depth of the cavity 2220.

The intermediate guide 2225 is flat and is configured to interface witha flat surface defined on the lateral side of the base 2131 of thestaple 2130; however, any suitable arrangement could be utilized. Incertain alternative embodiments, the intermediate guide 2225 comprises aresilient biasing member configured to apply a lateral biasing force tothe base 2131 of the staple 2130, for example. In at least one instance,the resilient biasing member could comprise a cantilever spring, forexample.

The staple cavity 2220 does not include a lateral guide positionedopposite the lateral intermediate guide 2225. In fact, a clearance gap2229 is present between a lateral sidewall 2228 and the staple 2130.

Further to the above, referring again to FIG. 43, the staple 2130 is notpositioned in the ends of the central slot 2221. More particularly, thecentral slot 2221 of the cavity 2220 comprises a proximal end 2226 and adistal end 2227 and the staple 2130 does not extend into either theproximal end 2226 or the distal end 2227. Rather, clearance gaps arepresent between the ends 2226, 2227 and the staple 2130. Such clearancegaps extend between the ends 2226, 2227 and the intermediate guide 2225.As a result, the ends 2226, 2227 of the staple cavity 2220 do notcontrol the longitudinal position of the staple 2130. Instead, thestaple leg guides 2222, 2223 control the longitudinal position of thestaple 2130. In fact, the legs 2132 and 2133 of the staple 2130 can bebiased inwardly by the staple leg guides 2222 and 2223, respectively.Such an arrangement creates longitudinal reaction forces, indicated asforce vectors LG in FIG. 43.

As a result of the above, the staple cavity 2220 comprises three controlpoints, or positions, in which the staple cavity 2220 controls theorientation of the staple 2130. These control points comprise discretecontrol positions with clearance gaps defined therebetween. Statedanother way, the guides 2222, 2223, and 2225 triangulate the control ofthe staple 2130. Alternative embodiments are envisioned which comprisemore than three control points. In any event, the control pointsprovided by the staple leg guides 2222 and 2223 are defined in a firstcontrol plane. An intermediate control point provided by theintermediate guide 2225 is defined in a second control plane. The firstcontrol plane and the second control plane are parallel; however,alternative embodiments are envisioned in which the first control planeand the second control plane are not parallel. Moreover, the firstcontrol plane is aligned with, or adjacent to, the staple legs 2132 and2133 of the staple 2130 and the second control plane is aligned with, oradjacent to, the base 2131 of the staple 2130.

A staple cartridge 2700 is illustrated in FIG. 65. The staple cartridge2700 comprises a cartridge body 2710 which includes a deck 2714 and aplurality of staple cavities 2220 defined in the deck 2714. Similar tothe cartridge body 2110, the cartridge body 2710 includes projections2752 and 2753 which extend above the deck 2714. The projections 2752 atleast partially surround the staple leg guides 2222 of the staplecavities 2220 and the projections 2753 at least partially surround thestaple leg guides 2223 of the staple cavities 2220. Similar toprojections 2152, 2153, the projections 2752, 2753 each include anoutside portion 2754 and a lateral portion 2755. The outside portions2754 are positioned longitudinally with respect to the staple leg guides2222 and 2223 while the lateral portions 2755 are positioned laterallywith respect to the staple leg guides 2222 and 2223. Unlike theprojections 2152, 2153, the projections 2752, 2753 each include an innerportion 2756 which are positioned longitudinally with respect to thestaple leg guides 2222 and 2223. The inner portions 2756 are connectedto the lateral portions 2755 and the lateral portions 2755 are connectedto the outside portions 2754. Similar to the above, the projections2752, 2753 extend the staple cavities 2220 above the deck 2714.

A staple cartridge 2800 is illustrated in FIG. 66. The staple cartridge2800 comprises a cartridge body 2810 which includes a deck 2814 and aplurality of staple cavities 2220 defined in the deck 2814. Similar tothe cartridge body 2110, the cartridge body 2810 includes projections2152, 2153 which extend above the deck 2114. As outlined above, theprojections 2152 at least partially surround the staple leg guides 2222of the staple cavities 2220 and the projections 2753 at least partiallysurround the staple leg guides 2223 of the staple cavities 2220.Moreover, the cartridge body 2810 includes inner projections 2856 whichare positioned longitudinally with respect to the staple leg guides 2222and 2223. The inner projections 2856 are not connected to theprojections 2152, 2153.

Referring again to FIG. 35, the staples 2130 are driven between unfiredpositions and fired positions by a firing member, such as sled 2140, forexample. The sled 2140 comprises wedges 2145 which are configured todirectly engage the staples 2130 and lift the staples 2130 toward ananvil, such as anvil 2190, for example, as illustrated in FIG. 37. Thesled 2140 comprises a wedge 2145 for each longitudinal row of staples2130; however, the sled 2140 may have any suitable number of wedges2145. Each wedge 2145 comprises an angled drive surface 2141 whichslides under the staples 2130 as the sled 2140 is advanced from theproximal end of the staple cartridge 2100 toward the distal end of thestaple cartridge 2100. The base 2131 of each staple 2130 comprises anangled drive surface 2135 which is directly contacted by a drive surface2141. Stated another way, each staple 2130 comprises its ownintegrally-formed driver having a drive surface 2135. The staples 2130are comprised of metal and, as a result, the integrally-formed driver isalso comprised of metal. That said, the staples disclosed herein can becomprised of any suitable material.

Further to the above, each drive surface 2141 comprises an initial, ordistal, portion 2142, a second, or intermediate, portion 2143, and athird, or apex, portion 2144. The initial portion 2142 extends at afirst angle and provides an initial contact point for the sled 2140against a staple 2130 as the sled 2140 is moved distally. As the initialportion 2142 slides under the staple 2130, the staple 2130 is liftedupwardly within the staple cavity 2120. As the sled 2140 continues tomove distally, the intermediate portion 2143 comes into contact with thestaple 2130. The intermediate portion 2143 extends at a second anglewhich is different than the first angle. The first angle can be steeperthan the second angle when it is desirable for there to be a quickinitial upward displacement of the staple 2130 whereas the first anglecan be shallower than the second angle when it is desirable to a providea gradual initial upward displacement of the staple 2130. In eitherevent, the staple 2130 contacts the anvil 2190 while the staple 2130 isbeing lifted upwardly by the intermediate portion 2143, as illustratedin FIG. 37; however, alternative embodiments are envisioned in which thestaple 2130 contacts the anvil 2190 when the staple 2130 is being liftedupwardly by the initial portion 2142. In either event, the proximal leg2132 of the staple 2130 contacts a proximal forming pocket 2192 definedin the anvil 2190 and the distal leg 2133 contacts a distal formingpocket 2193 defined in the anvil 2190. The forming pockets 2192 and 2193are configured to bend the legs 2132 and 2133 inwardly to deform thestaple 2130 and capture the tissue of a patient within the staple 2130.The apex 2144 of the drive surface 2141 slides under the staple 2130 tofinish the forming process. The apex 2144 can comprise a peak of thedrive surface 2141, a flat surface, and/or a surface which extends at athird angle which is different than the first angle and/or the secondangle.

In various instances, each drive surface 2141 can comprise a portionwhich trails, or is positioned proximal to, the apex 2144 of the drivesurface 2141. Such a trailing portion can be lower than the apex 2144,for example. Moreover, such a trailing portion can provide for a gradualdecrease in forming pressure in the staples 2130, for example.

Turning now to FIG. 39, the staple 2130 further includes a foot 2134which extends downwardly from the proximal leg 2132. When the staple2130 is in its proper orientation in its staple cavity 2120, asillustrated in FIG. 41, the foot 2134 is not contacted by the sled 2140.In such instances, an alignment plateau 2146 of the sled 2140 passesunder the foot 2134. When the staple 2130 is not in its properorientation in its staple cavity 2120, as illustrated in FIG. 42, thesled 2140 can contact the staple 2130 and re-orient the staple 2130. Forthe purpose of comparison, an improperly oriented staple 2130 and aproperly oriented staple 2130′ are both illustrated in FIG. 42. The sled2140 comprises an angled alignment ramp 2148 which is configured tocontact the foot 2134 and rotate the staple 2130 into is properorientation. After the alignment ramp 2148 has properly oriented thestaple 2130, the alignment plateau 2146 can slide underneath the foot2134. As can be appreciated from FIG. 39, the alignment ramp 2148, thealignment plateau 2146, and the foot 2134 are arranged in an alignmentplane which is aligned with the forming plane of the legs 2132 and 2133of the staple 2130. The alignment plane is adjacent to a lifting planewhich includes the forming surface 2141 of the sled 2140 and the base2131 of the staple 2130.

A staple cartridge assembly 2300 is illustrated in FIGS. 44-48. Thestaple cartridge assembly 2300 is similar to the staple cartridge 2000,2100, 2200, and the other staple cartridges disclosed herein in manyrespects. The staple cartridge 2300 comprises a cartridge body 2310 andsleds 2340 which are configured to eject staples removably stored in thecartridge body 2310. Similar to sled 2140, sleds 2340 comprise stapleforming ramps 2145. The ramps 2145 are slidably positioned inlongitudinal slots 2115 defined in the cartridge body 2110 which arealigned with the lifting portions, or planes, of the staples. Notably,as discussed in greater detail below, the slots 2115 have an open enddefined in the bottom 2316 of the cartridge body 2310.

Further to the above, the staple cartridge assembly 2300 does notinclude a cover extending around the bottom 2316 of the cartridge body2310. Referring primarily to FIG. 48, the cartridge body 2310 isdirectly positioned against the jaw 2180 of the stapling instrument. Inembodiments where a staple cartridge is not readily removable from thejaw of a stapling instrument and not readily replaceable with anotherstaple cartridge, the absence of a bottom cover is not necessarilyproblematic as the jaw 2180 can prevent the staples from falling out ofthe bottom of the staple cavities 2120 and/or the sleds 2340 fromfalling out of the bottom of the longitudinal slots 2115. The staplecartridge assembly 2300 is, however, replaceable and, even though itdoes not include a bottom cover, the staple cartridge assembly 2300includes features which keep the staples and the sleds 2340 from fallingout of the bottom 2316 of the cartridge body 2310, which are describedin greater detail further below. Such features could be adapted to anyof the staple cartridges disclosed herein.

Referring primarily to FIGS. 45-47, the cartridge body 2310 includesretention features configured to hold the sleds 2340 therein. Forexample, the cartridge body 2310 includes proximal retention features2317 which are configured to hold the sleds 2340 in the longitudinalslots 2115 when the sleds 2340 are in their proximal, or unfired,positions. The sleds 2340 are in their unfired positions when the staplecartridge assembly 2300 is inserted, or loaded, into the jaw 2180 and,as a result, the proximal retention features 2317 retain the sleds 2340in the cartridge body 2310 when the cartridge assembly 2300 is beinghandled by a clinician. Each retention feature 2317 includes an angledsurface 2318 and a shoulder 2319. Each sled 2340 includes acorresponding recess 2348 configured to receive an angled surface 2318and, in addition, a corresponding shoulder 2349 which can be alignedwith and/or contact a shoulder 2319 of the retention feature 2317. Whenthe sleds 2340 are inserted into the slots 2115, referring to FIG. 46,the ramps 2145 and/or the sidewalls of the cartridge 2310 can flex topermit the sleds 2340 to slide relative to the angled surfaces and thenresiliently snap back to their original positions once the shoulders2349 of the sleds 2340 have become aligned with the shoulders 2319 ofthe cartridge body 2310, as illustrated in FIG. 45. The retentionfeatures 2317 are also configured to prevent the sleds 2340 from slidingproximally out of the longitudinal slots 2115.

As a result of the above, the proximal retention features 2317 preventthe sleds 2340 from falling out of the cartridge body 2310 when aclinician is handling the staple cartridge assembly 2300. When the sleds2340 are advanced distally to fire the staples, the sleds 2340 are nolonger aligned with the proximal retention features 2317. At such point,however, the staple cartridge assembly 2300 is already in the jaw 2180and sled retention features are no longer needed. That said, thecartridge body 2310 can include additional retention features which canhold the sleds 2340 in the cartridge body 2310 regardless of theposition of the sleds 2340. Such retention features could be configuredto hold the sleds 2340 in the cartridge body 2310 when the sleds 2340are in their distal, or fully fired, positions, for example.

Further to the above, the staples of the staple cartridges disclosedherein can include one or more features configured to hold the staplesin the staple cavities of the staple cartridge. Turning now to FIGS. 49and 50, a staple 2330 includes a base 2331 and one or more staple legs2332 extending from the base 2331. The staple 2330 is removably storedin a staple cavity 2320 in the cartridge body 2310, for example. Thebase 2331 comprises a protrusion 2338 extending therefrom which isengaged with a sidewall of the staple cavity 2320. The interactionbetween the protrusion 2338 and the staple cavity sidewall keeps thestaple 2330 from falling out of the bottom 2316 of the cartridge body2310. The interaction between the protrusion 2338 and the staple cavitysidewall comprises an interference fit; however, such an interferencefit does not prevent the sleds 2340 from ejecting the staples 2330 fromthe staple cavities 2320. The protrusion 2338 can be formed in the base2331 during a stamping process, for example. The stamping process canform the protrusion 2338 by creating a dent 2337 in the opposite side ofthe base 2331. The staple cavity 2320 includes a vertical groove 2328which is aligned with the protrusion 2338. The groove 2328 increases thecontact area between the sidewall of the staple cavity 2320 and theprotrusion 2338. In addition, the groove 2328 can control theorientation of the staple 2330 within the staple cavity 2320.Alternative embodiments are envisioned which do not comprise the groove2328.

In addition to or in lieu of the above, the staples stored in the staplecartridges disclosed herein can include staple legs which areresiliently engaged with the sidewalls of their staple cavities. Turningnow to FIG. 51, a staple 2430 can include a base 2431 and staple legs2432 and 2433 extending from the base 2431. The staples 2430 are similarto the staples 2130, 2330, and/or the other staples disclosed herein inmany respects. A staple cartridge body 2410, for example, can include aplurality of staple cavities 2120 defined therein and a staple 2430positioned in each staple cavity 2120. FIG. 51 depicts a staple 2430positioned inside a cavity 2120 and a staple 2430 positioned outside astaple cavity 2120 of the cartridge body 2430. When the staples 2430 arenot positioned in the staple cavities 2120, the staple legs 2432, 2433do not extend in parallel directions; rather, they extend outwardly awayfrom each other. When the staples 2430 are positioned in the staplecavities 2120, they are flexed inwardly by the sidewalls of the staplecavities 2120. Stated another way, the staple legs 2432, 2433 areresiliently biased against the sidewalls of the staple cavities and,owing to this biased engagement, the staples 2430 are inhibited fromfalling out of the bottom 2436 of the cartridge body 2410. Asillustrated in FIG. 51, the distance between the staple legs 2432, 2433when the staples 2130 are positioned in the staple cavities 2120 is Xwhile the distance between the staple legs 2432, 2433 when the staples2130 are not positioned in the staple cavities is larger than X.

In various embodiments, a cartridge body can include one or moreshoulders which are configured to keep the staples stored therein fromfalling out of the bottom of the cartridge body. The shoulders can atleast partially extend underneath the staples.

In certain embodiments, the cartridge body of a staple cartridgeassembly can be comprised of plastic and can be formed during aninjection molding process, for example. The injection mold can includetwo halves which are movable toward and away from each other. Theinterface between the injection mold halves is often called a partingline and it is frequent that flashing, or seepage of the plastic betweenthe mold halves, can occur at the parting line. In at least oneembodiment, the parting line of an injection mold can be defined at theinterfaces between the deck of the staple cartridge and the staplecavities defined in the deck. As a result of the above, plastic flashingcan occur around the perimeter of the staple cavities. Such flashing canreleasably hold the staples in the staple cartridge.

Referring again to FIG. 48, the cartridge body 2310 is configured todirectly engage the jaw 2180. The jaw 2180 comprises one or moreretention shoulders 2315 defined therein. The cartridge body 2310comprises corresponding retention shoulders 2187 which co-operate withthe retention shoulders 2315 to releasably retain the cartridge body2310 in the jaw 2180. The cartridge body 2310 and/or the jaw 2180further comprise ramp surfaces 2314 which are configured to facilitatethe insertion of the cartridge body 2310 into the jaw 2180. As a resultof the above, the cartridge body 2310 can have a snap-fit relationshipwith the jaw 2180. The snap-fit relationship can be overcome by pryingthe cartridge body 2310 out of the jaw 2180 such that the staplecartridge assembly 2300 can be replaced.

A staple 2530 is illustrated in FIGS. 52-56. The staple 2530 is similarto the staples 2130, 2330, 2340, and/or the other staples disclosedherein in many respects. The staple 2530 comprises a base 2531 and legs2532 and 2533 extending from the base 2531. The staple 2530 alsoincludes a projection 2538 extending upwardly from the base 2531. Theprojection 2538 is aligned with the staple driving plane which includesthe base 2531 and is not aligned with tissue capture plane including thestaple legs 2532 and 2533. The projections 2538 can compress the tissueoutside of the staple capture plane.

A staple cartridge assembly 2600 is illustrated in FIGS. 57-64. Thestaple cartridge 2600 comprises a cartridge body 2610 including aplurality of staple cavities 2220 defined therein. The staple cartridge2600 further comprises a staple 2530 positioned in each staple cavity2220 and sleds 2640 configured to eject the staples 2530 from the staplecavities 2220. The sleds 2640 are similar to the sleds 2140 in manyrespects. Each sled 2640 comprises a plurality of ramps 2645 whereineach ramp 2645 comprises a drive surface 2641 configured to slide underthe staples 2530 and lift the staples 2530 within the staple cavities2220. Each drive surface 2641 includes an inclined surface 2643 boundedby lateral sidewalls 2649 which define a guide channel that aligns thestaples 2530 with respect to the drive surfaces 2641 and/or the staplecavities 2220. The guide channel is configured to receive the bases 2531of the staples 2530 between the sidewalls 2649 and orient the staples2530 laterally as the sled 2640 is advanced distally. Such lateralre-alignment is apparent upon comparing FIGS. 58 and 59. Referring againto FIGS. 52-56, each staple 2530 comprises a guide feature 2139 definedon the bases 2531 thereof. The guide feature 2139 of each staple 2530comprises a curved end, for example, which is configured to interactwith the lateral sidewalls 2649 of the guide channels and adjust thelateral position of the staples 2530. In various other embodiments, theguide features 2139 can comprise any suitable configuration.

In addition to or in lieu of the above, referring primarily to FIG. 60,the sleds 2640 comprise guide channels 2646 which are configured toreceive the downwardly depending feet 2134 of the staples 2530 andorient the staples 2530 with respect to the drive surfaces 2641 and/orthe staple cavities 2220. Each guide channel 2646 comprises a rampportion 2648 and lateral sidewalls. The guide channels 2646 areconfigured to receive the bases 2531 of the staples 2530 between thesidewalls of the channels 2646 and orient the staples 2530 laterally asthe sled 2640 is advanced distally. Referring primarily to FIG. 61, eachfoot 2134 comprises lead-in, or beveled, surfaces 2137 which areconfigured to interact with the sidewalls of the channels 2646 to guidethe staples 2530 into the channels 2646. That said, the feet 2134 cancomprise any suitable geometry which facilitates the entry of thestaples 2530 into the channels 2646. The reader should appreciate that,as the staples 2530 are driven upwardly within the staple cavities 2220by the drive surfaces 2641, the feet 2134 of the staples 2530 lift outof the channels 2646. By the time that the staples 2530 are being formedby the apexes 2644 of the drive surfaces 2641, the feet 2134 are nolonger positioned in the channels 2646.

Referring primarily to FIGS. 58, 59, and 64, the channels 2646 can alsoalign the sleds 2640 with respect to the cartridge body 2610. Moreparticularly, the cartridge body 2610 further comprises longitudinalrails 2616 extending downwardly into the channels 2646. The rails 2616are closely received in the channels 2646 to limit or prevent lateralmovement between the sleds 2640 and the cartridge body 2610 while permitthe longitudinal movement of the sleds 2640 needed to fire the staples2530 as outlined above. The foot 2134 of each staple 2530 is configuredto properly orient the staple 2530 within its staple cavity 2220 in theevent that the staple 2530 is misoriented within the staple cavity 2220.

The arrangements disclosed herein allow for a staple cartridge to bemore compact than previous staple cartridges. Among other things, thestaple cartridges disclosed herein that do not utilize staple driversbetween the firing member and the staples, i.e., driverless staplecartridges, allow the staple cartridges to have a shorter overallheight. Similarly, the staple cartridges that do not include a bottomcover also allow the staple cartridges to have a shorter overall height.Driverless staple cartridges can also allow smaller staple cavities tobe utilized. Turning now to FIGS. 67 and 68, a cartridge body 2910includes staple cavities 2920 and a longitudinal slot 2013 definedtherein. FIGS. 67 and 68 show the bottom 2916 of the cartridge body 2910and the bottom openings of the staple cavities 2920. The reader shouldappreciate that the staple cavities 2920 are sized and configured toreceive staple drivers for driving the staples out of the cartridge body2910. Turning now to FIGS. 69 and 70 which depicts the bottom 2016 ofthe cartridge body 2010, the staple cavities 2020 of the cartridge body2010 are smaller than the staple cavities 2920. As the reader willrecall, drivers are not positioned in the staple cavities 2020 and, as aresult, the size of the staple cavities 2020 can be reduced. FIG. 71compares the bottom 2916 of the cartridge body 2910 to the bottom 3016of an alternative embodiment of a cartridge body 3010. As can be seen inFIG. 71, the cartridge body 3010 includes longitudinal rows of staplecavities 3020 which are much narrower than the longitudinal rows ofstaple cavities 2920. In various instances, such narrower staplecavities can permit the center lines of the longitudinal rows of staplecavities to be closer to one another. Turning now to FIG. 72, a staplecartridge body 3110 includes longitudinal rows of staple cavities 3120a, 3120 b, and 3120 c defined in a deck 3114 of the cartridge body 3110which are positioned closer together than would be permitted inembodiments which use staple drivers to lift the staples within thecartridge body.

The various embodiments of the staple cartridge assemblies disclosedherein can have any suitable number of staples and/or any suitable sizeof staples. In certain instances, all of the staples stored in thestaple cartridge assembly 2000 (FIG. 73) have the same, or at leastsubstantially the same, size. Referring to FIG. 77, each staple 2130 inthe staple cartridge 2000 comprises an unformed, or unfired, overallheight H1 defined between the bottom of the base 2131 and the tips ofthe staple legs 2132, 2133. Similarly, each staple 2130 comprises atissue capture area defined between the top of the base 2131 and thetips of the staple legs 2132, 2133 which has the same height H2 when thestaples 2130 are in their unformed height.

In contrast to the above, a first group of staples stored in the staplecartridge 2000 can have a first unformed height H1 and a second group ofstaples can have a second unformed height H1 which is different than thefirst unformed height H1. Also in contrast to the above, a first groupof staples stored in the staple cartridge 2000 can have a first tissuecapture height H2 and a second group of staples can have a second tissuecapture height H2 which is different than the first tissue captureheight H2.

The first group of staples can be positioned in a first longitudinal rowof staple cavities 2120 while the second group of staples can bepositioned in a second longitudinal row of staple cavities 2120. In atleast one instance, the first row of staple cavities 2120 can beadjacent the knife slot 2013 in the step 2014″ of the cartridge body2010 while the second row of staple cavities 2120 can be adjacent thefirst row of staple cavities 2120 in the step 2014′ of the cartridgebody 2010. In at least one such instance, the first unformed height H1is shorter than the second unformed height H1, for example.

Further to the above, a third group of staples stored in the staplecartridge 2000 can have a third unformed height H1 which is differentthan the first unformed height H1 and/or the second unformed height H1.The third group of staples can be positioned in a third longitudinal rowof staple cavities 2120. In at least one instance, the third row ofstaple cavities 2120 can be adjacent the second row of staple cavities2120 in the deck 2014 of the cartridge body 2010. In at least one suchinstance, the second unformed height H1 is shorter than the thirdunformed height H1, for example. In addition to or in lieu of the above,the third group of staples can have a third tissue capture height H2which is larger than the second tissue capture height H2.

In various embodiments, the first group of staples, the second group ofstaples, and/or the third group of staples can be deformed to the sameoverall formed height. Alternatively, the first group of staples can bedeformed to a first formed height, the second group of staples can bedeformed to a second formed height, and/or the third group of staplescan be deformed to a third formed height. In such instances, the firstgroup of staples can apply a larger pressure to the tissue than thesecond group of staples and, similarly, the second group of staples canapply a larger pressure to the tissue than the third group of staples.

Turning now to FIGS. 74-76, staples having the same unformed height canbe deformed to different formed heights. For example, a firstlongitudinal row of staples, represented by staples 2130″, can bedeformed to a first formed height, a second longitudinal row of staples,represented by staples 2130′, can be deformed to a second formed height,and/or a third row of staples, represented by staples 2130, can bedeformed to a third formed height. The first formed height is shorterthan the second formed height, and the second formed height is shorterthan the third formed height, for example. In such instances, the firstgroup of staples can apply a larger pressure to the tissue than thesecond group of staples and, similarly, the second group of staples canapply a larger pressure to the third group of staples.

A staple 3230 is illustrated in FIGS. 78 and 79. The staple 3230comprises a base, or crown, 3231, a first leg 3232 extending from thebase 3231, and a second leg 3233 extending from the base 3231. Similarto the base 2131 of the staple 2130, the base 3231 of the staple 3230includes an inclined drive surface defined in a drive plane. Unlikestaple 2130, however, the first leg 3232 and the second leg 3233 definea staple forming plane which is transverse to, or non-parallel to, thedrive plane.

The staple 3230 further includes a platform 3238 extending from the base3231. The platform 3238 is integrally formed with the base 3231 and hasbeen folded over such that the platform 3238 extends laterally from thebase 3231. The platform 3238 is not directly connected to the legs 3232,3233. Instead, gaps 3237 are present between the platform 3238 and thelegs 3232, 3233. In various other embodiments, the platform 3238 isdirectly connected to the first leg 3232 and/or the second leg 3233. Theplatform 3238 extends in a plane, i.e., a support plane, which istransverse to the drive plane and the staple forming plane; however, theplatform 3238 can extend in any suitable direction. The platform 3238 isflat, or at least substantially flat; however, the platform 3238 cancomprise any suitable shape.

In certain embodiments, the platforms 3238 of the staples 3230 cancontact the tissue being stapled when the staples 3230 are implantedinto the tissue. The wider platform 3238 can reduce the possibility ofthe staples 3230 tearing through the tissue.

In various embodiments, a staple cartridge assembly comprises acartridge body including a deck and staple cavities defined in the deck.The staple cartridge assembly further comprises staples 3230 removablystored in the staple cavities and, in addition, an implantable layerpositioned over the deck. The implantable layer can comprise anysuitable adjunct such as a tissue thickness compensator and/or abuttress material, for example. A tissue thickness compensator cancompensate for variations in the thickness of the tissue being stapled.The implantable layer can be comprised of a woven material and/or anon-woven material, for example.

Further to the above, the platforms 3238 of the staples 3230 can abutthe layer when the staples 3230 are implanted into the tissue. In suchinstances, the platforms 3238 support the layer. Similar to the above,the platforms 3238 can also reduce the possibility of the staples 3230tearing through the layer. The platforms 3238 of the staples 3230 andthe layer can form a co-operative system which distributes the forces,stresses, and/or strains being applied to the tissue over a larger area.

The staple 3230 is formed from a flat sheet of material utilizing astamping process. During the stamping process, material is removed fromthe sheet to create the general shape of the staple 3230. The first leg3232 is bent in a first direction and the second leg 3233 is bent in asecond direction; however, both the first leg 3232 and the second leg3233 can be bent in any suitable direction by a die utilizing a singleline of action. The platform 3238 is bent in the same direction as thefirst leg 3232 during the stamping process, and/or a different stampingprocess. In certain instances, the platform 3238 can be createdutilizing the same single line of action that creates the legs 3232 and3233. In other instances, the platform 3238 can be created utilizing asecond line of action which is transverse or orthogonal to the firstline of action.

Turning now to FIG. 86, a staple 3630 comprises a base, or crown, 3631,and legs 3632 and 3633 extending from the base 3631. Similar to thestaple 3230, the staple 3630 further comprises a platform 3638 extendingfrom the base 3631. The reader should appreciate that the platform 3238of the staple 3230 and the platform 3638 of the staple 3630 can increasethe moment of inertia, or stiffness, of the staples. The staple 3630comprises a relief, or flex, slot 3637 in the base 3631 which decreasesthe stiffness of the staple 3630, for example. Additionally, oralternatively, a relief slot could be provided in the platform 3638. Inany event, more than one relief slot could be utilized to provide thedesired stiffness of the staple 3630. Moreover, such relief slots couldbe adapted to any of the staples disclosed herein.

In addition to or in lieu of the above, turning now to FIGS. 80 and 81,a staple assembly 3330 comprises a staple 3230 and an implantableadjunct 3370 attached to the staple 3230. The adjunct 3370 comprises afirst end including a first aperture 3372 configured to receive thefirst leg 3232 of the staple 3230 and a second aperture 3373 configuredto receive the second leg 3233. As a result, the adjunct 3370 istethered to the staple legs 3232, 3233 and the movement of the adjunct3370 relative to the staple 3230 is constrained.

Further to the above, the adjunct 3370 comprises a resilient portion3371 which extends over the platform 3238 of the staple 3230. A gap 3377is present between the resilient portion 3371 of the adjunct 3370 andthe platform 3238 of the staple 3230 when the staple assembly 3330 isstored in a staple cartridge. When the staple assembly 3330 is ejectedfrom the staple cartridge, the staple legs 3232, 3233 of the staples3230 penetrate the tissue being stapled and the resilient portion 3371of the adjunct 3370 comes into contact with the tissue. The resilientportion 3371 is configured to flex, deflect, and/or displace downwardlytoward the platform 3238 when the adjunct 3370 comes into contact withthe tissue. The resilient portion 3371 can apply a biasing force to thetissue when the tissue is captured within the staple 3230. The movementof the resilient portion 3371 is at least partially constrained by theplatform 3238.

In addition to or in lieu of the above, turning now to FIG. 84, a stapleassembly 3430 comprises a staple 3630 and an implantable adjunct 3470attached to the staple 3230. The adjunct 3470 comprises a first endincluding a first aperture 3472 configured to receive the first leg 3632of the staple 3630 and a second aperture 3473 configured to receive thesecond leg 3633. As a result, the adjunct 3470 is tethered to the staplelegs 3632, 3633 and the movement of the adjunct 3470 relative to thestaple 3630 is constrained.

Further to the above, the adjunct 3470 comprises a resilient portion3471 which extends over the platform 3638 of the staple 3630. Verylittle, if any, gap is present between the resilient portion 3471 of theadjunct 3470 and the platform 3638 of the staple 3630 when the stapleassembly 3430 is stored in a staple cartridge. When the staple assembly3430 is ejected from the staple cartridge, the staple legs 3632, 3633 ofthe staple 3630 penetrate the tissue being stapled and the resilientportion 3471 of the adjunct 3470 comes into contact with the tissue.Referring to FIG. 85, the resilient portion 3471 is configured to flex,deflect, and/or displace downwardly toward the platform 3638 when theadjunct 3470 comes into contact with the tissue. The resilient portion3471 can apply a biasing force to the tissue when the tissue is capturedwithin the staple 3630. The movement of the resilient portion 3471 is atleast partially constrained by the platform 3638.

Referring primarily to FIGS. 82 and 83, the resilient portion 3471 ofthe adjunct 3470 comprises an enclosure. The enclosure is sealed andincludes at least one material therein. In various instances, thematerial comprises a medicament. The medicament is released from theenclosure when the enclosure is ruptured. The enclosure can rupture whenthe staple assembly 3430 is implanted in the tissue or after a period oftime. The adjunct 3470 is comprised of any suitable biocompatiblematerial and, when the biocompatible material comprises a bioabsorbablematerial, the adjunct 3470 can be absorbed in situ. After a sufficientamount of the adjunct 3470 has been absorbed, the medicament can bereleased from the adjunct 3470. In various alternative embodiments, anadjunct comprises two separate enclosures. In at least one suchembodiment, a first enclosure can contain a first medicament and asecond enclosure can contain a second medicament. The first medicamentcan mix with the second medicament when the enclosures have beenruptured.

Further to the above, the material in the chamber of the resilientportion 3471 can be selected for its mechanical properties such as itselasticity, for example, and can provide the resilient portion 3471 withdesirable properties to apply a sufficient biasing force to the tissue.In at least one instance, it may be desirable for the resilient portion3471 to have mechanical properties which closely resemble that ofpatient tissue. In other instances, it may be desirable for theresilient portion 3471 to have a stiffness less than the stiffness ofpatient tissue, for example. Such embodiments may provide a suitableconstriction of blood flow within the tissue. In some instances, it maybe desirable for the resilient portion 3471 to have a stiffness which isless than the stiffness of the base 3631 but greater than the stiffnessof the patient tissue, for example. Such embodiments may provide strainrelief to the tissue.

The adjuncts 3370, 3470 can be comprised of a woven material and/or anon-woven material. In at least one instance, the adjuncts 3370, 3470comprise shells which are comprised of a woven material and/or anon-woven material. The adjuncts 3370, 3470 can be comprised of PGAand/or PLA, for example. In at least one instance, the adjuncts 3370,3470 comprise shells which are comprised of PGA and/or PLA, for example.

The adjuncts 3370, 3470 are configured to be attached to a singlestaple. Stated another way, each adjunct 3370, 3470 are only attached toone staple. Such adjuncts can be referred to as pledgets. Alternativeembodiments are envisioned in which two or more staples are connected byan adjunct.

Turning now to FIGS. 88 and 89, the various staples disclosed herein,such as staples 2130, for example, can be implanted into the tissue of apatient in longitudinal rows. Two longitudinal rows of staples 2130 aredepicted in FIGS. 88 and 89. In various instances, the tissue maystretch in various directions, such as longitudinally, for example. Thelongitudinal stretch of tissue T is depicted in FIG. 89. As can be seenin FIG. 89, the rows of staples 2130 can stretch along with the tissueT. In such instances, the gaps between the staples 2130 can increase.This gap increase is readily apparent when comparing the unstretched gapdistance X1 (FIG. 88) to the stretched gap distance X2 (FIG. 89). Thestaples 2130 in a third longitudinal row can be positioned and arrangedsuch that they are aligned with or co-extensive with the gaps whether ornot the gaps are stretched (X2) or unstretched (X1). Such concepts couldbe readily adapted to circular and/or curved staple rows, for example.

Turning now to FIG. 87, a circular cartridge body 3510, for example, canutilize the staple assemblies 3430. The cartridge body 3510 comprises aplurality of staple cavities 3520 arranged in circular, concentric rows.As illustrated in FIG. 87, each staple cavity includes a staple assembly3430 positioned therein; however, any suitable staple could be utilized.

The staples disclosed herein can be comprised of any suitable material.In various instances, the staples are comprised of stainless steeland/or titanium, for example. In certain instances, the staplesdisclosed herein are comprised of magnesium. The entire disclosures ofCOMPARISON OF THE EFFECTS OF Mg-6Zn AND Ti-3 Al-2.5V ALLOYS ONTGF-β/TNF-α/VEGF/b-FGF IN THE HEALING OF THE INTESTINAL TRACT IN VIVO,Biomed. Mater. 9 (2014) 025011, by Yan et al.; COMPARISON OF THE EFFECTSOF Mg-6Zn AND TITANIUM ON INTESTINAL TRACT IN VIVO, J. Mater. Sci.:Mater. Med., by Yan et al. which published online on Mar. 20, 2013;EVALUATION OF THE SOFT TISSUE BIOCOMPATIBILITY OF MgCa0.8 AND SURGICALSTEEL 316L IN VIVO: A COMPARATIVE STUDY IN RABBITS, Biomed. Eng. OnLine2010 9:63, by Erdmann et al.; INVESTIGATION OF THE MECHANICAL ANDDEGRADATION PROPERTIES OF Mg—Sr AND Mg—Zn—Sr ALLOYS FOR USE AS POTENTIALBIODEGRADABLE IMPLANT MATERIALS, J. Mech. Behavior of Biomed. Mat. 7(2012) 87-95, by Brar et al.; Mg—Zr—Sr ALLOYS AS BIODEGRADABLE IMPLANTMATERIALS, Acta Biomaterialia 8 (2012) 3177-3188, by Li et al.; ON THEBIODEGRADABILITY, MECHANICAL BEHAVIOR, AND CYTOCOMPATABILITY OFAMORPHOUS Mg₇₂Zn₂₃Ca₅ AND CRYSTALLINE Mg₇₀Zn₂₃Ca₅Pd₂ ALLOYS AS TEMPORARYIMPLANT MATERIALS, Soc. Biomat., by Pellicer et al., which publishedonline on Aug. 28, 2012, are incorporated by reference herein. In atleast one instance, the staples are comprised of a magnesium alloyincluding zinc and/or silver, for example. Staples including alloys ofmagnesium and zinc increase the healing performance of tissue. Staplesincluding silver provide anti-microbial benefits. Staples including allthree alloys provide a synergistic dynamic.

Staples comprised of magnesium, including those comprised of a magnesiumalloy, can be treated to improve the hardness of the staples. In variousinstances, a magnesium nitride coating is applied to the magnesiumstaples. The magnesium nitride coating is applied the entirety of themagnesium staples in certain instances while, in other instances, themagnesium nitride coating is applied to only portions of the magnesiumstaples. For instance, it may be desirable to coat only the staple legsand/or the tips of the staple legs in magnesium nitride as the staplelegs need to have a sufficient hardness to penetrate the tissue. In atleast one such instance, a mask can be applied to the remainder of themagnesium staple when the magnesium nitride coating is applied to thestaple legs. The magnesium nitride coating can be created by introducingthe magnesium staples to a nitrogen-rich environment at an elevatedtemperature and/or pressure, for example.

In addition to or in lieu of the above, one or more surfaces of themagnesium staples can include a coating including carbon.

In addition to or in lieu of the above, other surface hardeningtechniques could be utilized. For example, the magnesium staples couldbe hardened using a laser hardening process and/or a plasma dischargehardening process. In at least one instance, a KERONITE ceramic surfacetreatment, by Keronite International, can be applied to the staples.

As discussed above, certain portions of the magnesium staples mayundergo a hardening process while other portions of the magnesiumstaples may not undergo a hardening process. In some instances, certainportions of the magnesium staples can be hardened to a first hardnesswhile other portions of the magnesium staples can be hardened to asecond hardness which is different than the first hardness. The portionsof the magnesium staples having a lower hardness will elude magnesium,zinc, and/or silver ions, for example, faster than the portions of themagnesium staples having a higher hardness.

In addition to or in lieu of the above, magnesium staples, includingthose comprised of a magnesium alloy, can be at least partially coveredin a coating including silver. In at least one instance, the silvercoating can include ionized silver, for example. In certain instances,an electroplating process can be utilized to apply the silver coating tothe magnesium staples. In various instances, the entirety of themagnesium staples are covered in a silver coating. In at least oneinstance, a portion, or portions, of the magnesium staples are maskedduring the electroplating process such that the masked portions are notcoated, or at least substantially coated, in silver.

In addition to or in lieu of the above, the staples disclosed herein canbe coated, or at least partially coated, in an anti-microbial coating.Such a coating can comprise triclosan, for example. In at least oneinstance, the triclosan is mixed in an absorbable polymer coating. Incertain instances, the coating can comprise LAE intermixed with sodiumstearate, for example. The entire disclosure of WO 2012013577 A1,entitled COMPOSITION FOR COATING MEDICAL DEVICES CONTAINING LAE AND APOLYCATIONIC AMPHOTERIC POLYMER, by Gaffar et al., is incorporated byreference herein.

Turning now to FIGS. 90-92, a staple 3730 comprises a metal frame and acoating 3739 on less than the entirety of the metal frame. The metalframe includes the staple 2130 and is comprised of magnesium and/or amagnesium alloy, for example. The coating 3739 includes a bioabsorbablepolymer; however, the coating 3739 can comprise any suitable material.The coating 3739 extends around the legs 2132, 2133 of the metal frame2130. More specifically, the coating 3739 spirals around each of thelegs 2132, 2133; however, any suitable arrangement of the coating 3739could be utilized. The coating 3739 also covers the transitions, orcorners, between the legs 2132, 2133 and the base, or crown, 2131 of themetal frame 2130. The coating 3739 could also cover a portion of thebase 2131. In various instances, the coating 3739 can be strategicallyapplied to areas of the metal frame 2130 that are inherently susceptibleto faster bioabsorption, such as the bends, edges, and/or corners of themetal frame 2130, for example. In any event, a portion of the metalframe 2130 is covered by the coating 3739 while a portion of the metalframe 2130 is exposed.

The magnesium, or magnesium alloy, metal frame 2130 is bioabsorbable.Referring primarily to FIG. 91, the portions of the metal frame 2130that are not covered by the coating 3739 are directly exposed to thebody when implanted, and, thus, immediately subjected to the body'snatural absorption process. The portions of the metal frame 2130 thatare covered by the coating 3739 are not directly exposed to the body, atleast not initially, when implanted. The coating 3739 protects, or atleast somewhat protects, the portions of the metal frame 2130 that itcovers and delays the bioabsorption of such portions. Over time,referring primarily to FIG. 92, the unprotected portions of the metalframe 2130 will bioabsorb, leaving behind the portions of the metalframe 2130 that are protected by the coating 3739. The coating 3739 cansubstantially encapsulate the portions of the metal frame 2130 that itcovers, at least until the coating 3739 itself is bioabsorbed and/oruntil the metal frame 2130 has sufficiently broken apart. At such point,the portions of the metal frame 2130 that the coating 3739 onceprotected are exposed and can be bioabsorbed by the body.

The bioabsorbable polymer of the coating 3739 can be comprised of PGAand/or PLA, for example; however, the coating 3739 can be comprised ofany suitable material including, but not limited to, bioabsorbablepolymers and non-bioabsorbable polymers. In certain instances, thecoating 3739 comprises a non cross-linked polymer, for example. Such apolymer can cause the coating 3739 to swell and encapsulate any sharpedges of the metal frame 2130 that are created when the metal frame 2130deteriorates.

In various embodiments, the coating 3739 can be arranged in a grid,mesh, and/or lattice arrangement on the metal frame 2130 In such anembodiment, the metal frame 2130 can be exposed in the openings in thegrid which can allow the metal frame 2130 to be bioabsorbed in suchopenings. As the metal frame 2130 begins to deteriorate, the latticedcoating 3739 can act as a net or cage and hold the fragments of themetal frame 2130 together, for example, at least until the coating 3739is bioabsorbed.

The coating 3739 can be applied to the metal frame 2130 in any suitablemanner. In at least one instance, the coating 3739 can be sprayed ontothe metal frame 2130 such that the coating 3739 is applied in a randommanner which creates random openings through which the metal frame 2130can be bioabsorbed. In certain other instances, the coating 3739 can beapplied to the metal frame 2130 in a pattern. In at least one suchinstance, the pattern can include a dot-matrix pattern having islands ofcoating surrounded by exposed portions of the metal frame 2130.

In certain alternative embodiments, a staple can include two or morecoatings. In at least one such instance, a first coating can bebioabsorbed at a first rate and a second coating can be bioabsorbed at asecond rate to expose different portions of the metal frame 2130 atdifferent times during the healing process, for example. Such staplescan still have uncovered portions; however, it is contemplated thatevery portion of a staple could be covered by at least one or morecoatings.

The therapeutic benefits provided by the materials disclosed herein area function of the surface area of the staples that is exposed to thepatient's body. Staples having a larger surface area may deliver suchtherapeutic benefits faster than staples having a smaller surface area.That said, staples having a smaller surface area may provide suchtherapeutic benefits over a longer period of time. Nonetheless, thesurface area of the staples disclosed herein can be increased byintroducing apertures into the staples. For instance, one or moreapertures, or through holes, can be created in the base, or crown, 2131of the staple 2130, for example. The through holes can permit tissue togrow through the staple 2130 and improve the assimilation of the staple2130 into the body.

In at least one embodiment, further to the above, the coating 3739 isnot positioned in the apertures as the coating 3739 would reduce theavailable surface absorption area of the staple 2130. However, ifdelaying the bioabsorption of these staple portions is desired, theapertures in the staple 2130 could be filled, or at least partiallyfilled, with the coating 3739. As discussed above, the coating 3739 canbe configured to delay the absorption of the underlying metal frame;however, any suitable coating could be utilized. For example, a coatingon the metal frame could encourage tissue ingrowth into the structure ofthe staple. In at least one such instance, the coating comprises smallmicropillars that create a porous and/or prickly interaction with thetissue.

In various embodiments, further to the above, a suture, or string, canextend through the apertures defined in the staples. Such a suture cantether the staples together. In various instances, the suture isthreaded through the apertures while the staples are positioned in thestaple cartridge. In other instances, the suture is threaded through theapertures after the staples have been implanted into the tissue. In atleast one embodiment, the suture is positioned in a groove defined inthe deck of the staple cartridge and the staples each comprise a slot orhook defined therein which is configured to catch the suture as thestaples are being deployed. In any event, the suture can be pulled togather the stapled tissue together, such as in a purse-string tissuegathering technique, for example.

In various embodiments, the staples disclosed herein can comprise barbs.In at least one instance, barbs are defined on the staple leg such thatthe barbs engage a layer that is implanted with the tissue. Such barbscan reduce relative movement between the layer and the staples. Incertain embodiments, barbs are defined on the base of the staple. Suchbarbs can grip a layer of tissue positioned adjacent the implantedstaples.

A circular surgical stapler 5000 is depicted in FIGS. 93-95. Thecircular surgical stapler 5000 comprises a frame assembly 5020comprising an attachment portion 5021 configured to operably couple ananvil to the circular surgical stapler 5000. The circular surgicalstapler 5000 further comprises a knife member 5040 configured to incisetissue captured by the circular surgical stapler 5000, a surgical staplecartridge 5010 which removably stores a plurality of staples 5051therein, and a pusher assembly, or driver, 5030 configured to eject thestaples 5051 out of the staple cartridge 5010. The surgical staplecartridge 5010 comprises a cartridge deck 5013 and a plurality of staplecavities 5011 defined in the cartridge deck 5013 which removably storethe staples 5051. The staples 5051 are similar to the staples discussedin greater detail herein, however, any suitable staple may be used. Thestaples 5051 comprise staple legs in a plane which is offset from aplane defined by the staple base portion.

Referring primarily to FIG. 95, the staple cavities 5011 of the staplecartridge 5010 comprise an inner row of staple cavities 5011A, anintermediate row of staple cavities 5011B, and an outer row of staplecavities 5011C. Staple row spacing may can include any suitable spacing;however, nested rows may be closer together than non-nested rows. Theintermediate row of staple cavities 5011B is positioned radially outwardwith respect to the inner row of staple cavities 5011A. The outer row ofstaple cavities 5011C is positioned radially outward with respect to theintermediate row of staple cavities 5011B. The staple cavities 5011A inthe inner row comprise an orientation which orients the staple legs ofthe staples 5051 stored therein such that the staple legs extendradially outward with respect to the staple base. The intermediate rowof staple cavities 5011B and the outer row of staple cavities 5011Ccomprise an orientation which orients the staple legs of the staples5051 stored therein such that the staple legs extend radially inwardwith respect to the staple bases.

The staple cavities 5011A in the inner row define a plurality of firstgaps therebetween having a distance A. The intermediate row of staplecavities 5011B define a plurality of second gaps with a distance B. Theouter row of staple cavities 5011C define a plurality of third gaps witha distance C. The distance A is less than the distances B and C. Thedistance B is greater than the distance A but less than the distance C.The distance C is greater than the distances A and B. The cavities 5011are arranged such that the first gaps comprise a distance which isgreater than the distances of the second gaps and/or the third gaps. Thecavities 5011 are arranged such that the third gaps comprise a distancewhich is less than the distances of the first gaps and/or the secondgaps. Embodiments are envisioned where there are no gaps associated withone or more rows of staple cavities.

The intermediate row of staple cavities 5011B are arranged such that thecavities 5011B overlap the first gaps defined by the inner row of staplecavities 5011A in order to compensate for the lack of tissue ligation inthe first gaps. The outer row of staple cavities 5011C are arranged suchthat the cavities 5011C overlap the second gaps defined by theintermediate row of staple cavities 5011B in order to compensate for thelack of tissue ligation in the second gaps. Overlapping these fasteninggaps with such an arrangement increases the ligation ability of thecircular surgical stapler 5000. This arrangement also permits thefastened tissue to flex upon fastening. Conventional arrangementsutilize greater quantities of staples in the intermediate and/or outerrows in order to increase ligation efficiency; however, suchconventional arrangements can limit tissue flexibility after fastening.

FIGS. 96-98 illustrate a circular surgical stapler 5100 in accordancewith at least one embodiment. The circular surgical stapler 5100comprises a frame assembly 5120 comprising an attachment portionconfigured to operably couple an anvil to the circular surgical stapler5100. The circular surgical stapler 5100 further comprises a knifemember 5140 configured to incise tissue captured by the circularsurgical stapler 5100, a surgical staple cartridge 5110 which removablystores a plurality of staples 5151 therein, and a pusher assembly, ordriver, 5130 configured to eject the staples 5151 out of the staplecartridge 5110. The pusher assembly 5130 comprises an inner row ofstaple drivers 5130A, an intermediate row of staple drivers 5130B, andan outer row of staple drivers 5130C. The surgical staple cartridge 5110comprises a cartridge deck 5113 and a plurality of staple cavities 5111defined in the cartridge deck 5113 which removably store the staples5151 therein. The surgical staple cartridge 5110 further comprises aplurality of deck features, or staple supports, or guides, 5115configured to support, guide, and/or control the staples 5151 when thestaples 5151 are ejected from the staple cartridge 5110. The deckfeatures, or cavity extenders, 5115 can have a multitude of purposessuch as aiding in the gripping of tissue intermediate the anvil and thestaple cartridge 5110 and/or storing, releasing, and delivering amedicament to tissue captured with the stapler 5100, for example.

The staple cavities 5111 of the staple cartridge 5110 are similar to thestaple cavities 5011 in many respects. The staple cavities 5111 comprisean inner row of staple cavities 5111A, an intermediate row of staplecavities 5111B, and an outer row of staple cavities 5111C. The deckfeatures 5115 comprise a plurality of first deck features 5115A, aplurality of second deck features 5115B, and a plurality of third deckfeatures 5115C. Each first deck feature 5115A comprises an intermediateportion 5116 and two outer portions 5117 to define a T-configuration.The intermediate portion 5116 sits between two staple cavities 5111A andextends from the deck 5113 to guide and/or support neighboring staplelegs. The outer portions 5117 branch off of the intermediate portion5116 in at least substantially opposite directions and extend from thedeck 5113 to guide and/or support a portion of a staple base. Combiningdeck features for more than one cavity in such a manner can save spaceon the cartridge deck 5113.

Each second deck feature 5115B and each third deck feature 5115Ccomprise an intermediate portion 5118 and two outer portions 5119 todefine a cavity-surrounding configuration. The intermediate portion 5118extends from the deck 5113 to guide and/or support staple bases ofstaples removably stored in the intermediate row of staple cavities5111B and the outer row of staple cavities 5111C. The two outer portions5119 branch off from the intermediate portion 5118 to support the staplelegs that extend from the staple base that the intermediate portion 5118is guiding and/or supporting.

FIG. 99 illustrates a circular stapling configuration 5200 for use witha circular surgical stapler in accordance with at least one embodiment.The circular stapling configuration 5200 is an arrangement of staplesemployable with a circular staple cartridge. A circular staple cartridgeemploying the circular stapling configuration 5200 comprisescorresponding staple cavities to removably store the staples discussedherein. The circular stapling configuration 5200 comprises a pluralityof staples 5210 comprising an inner row of staples 5213, an intermediaterow of staples 5215, and an outer row of staples 5217. Each staple 5213is orientated such that its staple legs face outward toward the outerrow of staples 5217. Each staple 5215 is orientated such that its staplelegs face inward toward the inner row of staples 5113. Each staple 5217is orientated such that its staple legs face outward away from the innerrow of staples 5213 and the intermediate row of staples 5215. Eachstaple row may reside a certain distance from each other staple rowand/or the cutting member to better control blood flow and/or predicttissue behavior at certain points within the stapled tissue.

The outer row of staples 5217 comprise different characteristics thanthe inner and/or intermediate row of staples 5213, 5215. For example, invarious instances, the outer row of staples 5217 are formed into alarger “B” formation resulting in a greater capture volume and/or tallerstaple forming height to alleviate high tissue compression near theouter row of staples 5217. A larger B formation may also improve bloodflow toward the inner rows. In various instances, the outer row ofstaples 5217 comprise a greater resistance to unfolding by utilizing alarger staple crown, staple leg widths, and/or staple leg thicknesses.

The quantity of staples used in each row of staples can vary in acircular and/or linear surgical staple cartridge. The outer row ofstaples 5217 comprise a first quantity, the intermediate row of staples5215 comprise a second quantity, and the inner row of staples 5213comprise a third quantity. FIG. 99 illustrates a scenario where thefirst quantity is equal to the second quantity, but, greater than thethird quantity. In various embodiments, the first quantity, the secondquantity, and the third quantity are different. In various embodiments,the first quantity is greater than the second quantity and the secondquantity is greater than the third quantity.

Varying staple crown widths between staple rows can provide an effectiveand/or efficient stapling arrangement. For example, each outer rowstaple 5217 comprises a staple crown having a width that is greater thanthe crown width of each inner row staple 5213 and each intermediate rowstaple 5215. The staple crown of each outer row staple 5217 is bentlaterally in order have a larger crown width staple while maintainingthe compact circular stapling arrangement. Some embodiments areenvisioned where the crown of each outer row staple 5217 is curved. Oneadvantage of bending or curving the crown of the outer row staples 5217can include being able to nest the outer row staples 5217 closer to theintermediate row staples 5215 and the inner row staples 5213, forexample. Each outer row staple 5217 spans a plurality of gaps definedbetween the inner row staples 5213 and/or the intermediate row staples5215. Each intermediate row staple 5215 spans, overlaps, or covers eachgap defined between the inner row of staples 5213.

In various embodiments the gaps defined by the inner row staples 5213can be varied based on the radial position of the row of inner staples.For example, a row of inner staples having a diameter much less than thediameter of the intestine being stapled may comprise much larger gapsbetween the inner row staples to provide radial flexibility, and/orexpansion. A row of inner staples having a diameter less than, butcloser to, the diameter of the intestine being stapled may comprisesmaller gaps between the inner row staples because, in this instance,vast expansion and/or flexibility may not be necessary.

FIG. 100 illustrates a circular stapling configuration 5300 for use witha circular surgical stapler in accordance with at least one embodiment.The circular stapling configuration 5300 is an arrangement of staplesemployable with a circular staple cartridge. A circular staple cartridgeemploying the circular stapling configuration 5300 comprisescorresponding staple cavities to removably store the staples discussedherein. The circular stapling configuration 5300 comprises a pluralityof staples 5310 comprising inner row staples 5313A, 5313B, intermediaterow staples 5315C, 5315D, and outer row staples 5317E, 5317F. Eachstaple 5313A, 5313B is orientated such that the staple legs thereof faceoutward toward the outer row staples 5317E, 5317F. Each staple 5315C,5315D is orientated such that the staple legs thereof face inward towardthe inner row staples 5313A, 5313B. Each staple 5317E, 5317F isorientated such that the staple legs thereof face outward away from theinner row staples 5313A, 5313B and the intermediate row staples 5315C,5315D. Embodiments are envisioned where various staples within the samerow face opposite directions. Embodiments are envisioned where everystaple in every row faces the same direction. Embodiments are envisionedwhere the inner row staples face inward, the intermediate row staplesface outward, and the outer row staples face inward, for example.

Varying staple crown widths between and within staple rows can alsoprovide a an effective and/or efficient stapling arrangement. Forexample, the inner row staples 5313A, 5313B each comprise a differentcrown width, the intermediate row staples 5315C, 5315D each comprise adifferent crown width, and the outer row staples 5317E, 5317F eachcomprise a different crown width. In various embodiments, the crownwidths of each staple 5313A, 5313B, 5315C, 5315D, 5317E, and 5317F areall different. Embodiments are envisioned where crown widths of certainstaples in one row are equal to crown widths of certain staples inanother row. The inner row staples define a stretch zone labeled SZ. Thestretch zone SZ can comprise a gap defined between the staples 5313A,for example. The stretch zone SZ permits the stapled tissue to flex.

The circular surgical staplers, circular staple cartridges, and/orcircular stapling configurations may be employed in a colectomyprocedure, for example. FIG. 101 illustrates an example of a part of acolectomy procedure where two portions of intestine are joined providinga new pathway, or passage, 5400 for the digestive system. One portion ofintestine T₁ comprises an inner wall 5410 and a second portion ofintestine T₂ comprises an inner wall 5420. The intestine portions T₁ andT₂ are stapled with inner staples 5401, intermediate staples 5403, andouter staples 5405. The intestine portions T₁ and T₂ are incisedcreating a new passage P-P for digestive material to pass. The incisioncreates cut portions 5411 and 5421 of the intestine portions T₁ and T₂.The change in diameter between the inner walls 5410, 5420 of theintestine portions T₁ and T₂ and the cut portions 5411, 5421 can, insome cases, constrict, or narrow, the passage P-P making it difficultfor digestive material to pass. It can be desirable to have flexibilityof the staple portion starting with the inner staples 5401. One methodfor providing flexibility utilizes staple gaps defined between staplesin the various rows in which the staples are arranged. Another methodfor providing flexibility utilizes larger sized staples with largerstaple crowns. In various instances, gaps between the staples and staplerows permit flexibility of the stapled portion allowing digestivematerial to pass more easily. In various instances, different sizestaples permit tissue flexibility.

FIGS. 102-104 depict a curved stapling instrument 5500 in accordancewith at least one embodiment configured to capture, incise, and stapletissue. The curved stapling instrument 5500 comprises a frame assembly5510, a staple cartridge 5520, and an anvil 5530. Upon receiving a firstactuation force, the staple cartridge 5520 is driven toward the anvil5530 to capture tissue therebetween. The curved stapling instrument 5500further comprises a knife assembly 5540 comprising a cutting member 5541configured to incise the tissue captured between the staple cartridge5520 and the anvil 5530. The staple cartridge 5520 comprises a deck 5527comprising a cutting slot 5521 configured to receive the cutting member5541, a plurality of staple cavities 5523A and 5523B, and a plurality ofstaples 5560 removably stored within the staple cavities 5523A, 5523B.The curved stapling instrument 5500 further comprises a driver assembly5550 comprising a plurality of staple drivers 5551 configured to drivethe staples 5560 toward the anvil 5530 upon the application of a secondactuation force. The second actuation force is responsible for liftingthe driver assembly 5550 and the knife assembly 5540 vertically relativeto the curved stapling instrument 5500 in order to incise and staple thetissue.

The staple cartridge 5520 further comprises a plurality of deck features5525 extending from the deck 5527. Embodiments are envisioned where thedeck features 5525 are separate portions configured to be attached tothe deck 5527. The deck features 5525 can be extensions of the staplecavities 5523A, 5523B in order to support, guide, and/or control thestaples 5560 while loading the staples 5560 into the cartridge 5520,while housing, or supporting, the staples 5560 before ejecting thestaples 5560, and/or while ejecting the staples 5560 from the cartridge5520. A single deck feature 5525 supports two different staple legs ofneighboring staples. The deck features 5525 can comprise multiplesupport walls configured to support one or more sides, faces, and/oredges of each staple leg. Embodiments are envisioned where the deckfeatures 5525 on the outer staple rows, rows furthest from the slot,only correlate with every other staple cavity in each outer row. Staplefeatures may increase in density the closer to the incision the staplefeatures are positioned.

FIGS. 105 and 106 depict a curved stapling instrument 5600 in accordancewith at least one embodiment configured to capture, incise, and stapletissue. The curved stapling instrument 5600 comprises a frame assembly5610, a staple cartridge 5620, and an anvil 5630. Upon receiving a firstactuation force, the staple cartridge 5620 is driven toward the anvil5630 to capture tissue therebetween. The curved stapling instrument 5600further comprises a knife assembly comprising a cutting memberconfigured to incise the tissue captured between the staple cartridge5620 and the anvil 5630. The staple cartridge 5620 comprises a deck 5627comprising a cutting slot 5621 configured to receive the cutting member,a plurality of staple cavities 5623, and a plurality of staples 5660removably stored within the staple cavities 5623. The curved staplinginstrument 5600 further comprises a driver assembly 5650 comprising aplurality of staple drivers 5651 configured to drive the staples 5660toward the anvil 5630 upon the application of a second actuation force.The second actuation force is responsible for lifting the driverassembly 5650 and the knife assembly vertically relative to the curvedstapling instrument 5600 in order to incise and staple the tissue.

The staple cartridge 5620 further comprises a plurality of deck features5625 extending from the deck 5627. Embodiments are envisioned where thedeck features 5625 are separate portions configured to be attached tothe deck 5627. The deck features 5625 can be extensions of the staplecavities 5623 in order to support, guide, and/or control the staples5660 while loading the staples 5660 into the cartridge 5620, whilehousing, or supporting, the staples 5660 before ejecting the staples5660, and/or while ejecting the staples 5660 from the cartridge 5620.The deck features 5625 can comprise multiple support walls configured tosupport one or more sides, faces, and/or edges of each staple leg. Thedeck features 5625 extend from at least one of the staple leg walls andat least one of the staple base walls of the staple cavities.

The staple drivers 5651 comprise a flat profile which is at leastsubstantially the same as the bottom profile of the staples 5660. Havingsimilar, or the same, profiles permits an adequate force distribution bythe staple drivers 5651 over the staple base portions of the staples5660. When being formed against the anvil 5630, the similar profilesbetween the drivers 5651 and the staples 5660 prevents the staples 5660becoming misaligned.

EXAMPLES Example 1

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal end, a distal end, a deck, a longitudinal slot defined in thedeck extending from the proximal end toward the distal end and staplecavities, wherein the staple cavities are arranged in longitudinal rows.Each staple cavity comprises a top opening defined in the deck, a bottomopening, a proximal end, a distal end, and a staple cavity sidewallextending between the proximal end and the distal end. The staplecartridge assembly further comprises staples removably stored in thestaple cavities, wherein each staple comprises a proximal leg, a distalleg, a base extending between the proximal leg and the distal leg, and aretention projection extending from the base, wherein the retentionprojections of the staples are engaged with the staple cavity sidewallsto prevent the staples from falling out of the bottom openings of thestaple cavities.

Example 2

The staple cartridge assembly of Example 1, further comprising a sledmovable from the proximal end toward the distal end to eject the staplesthrough the top openings of the staple cavities.

Example 3

The staple cartridge assembly of Example 2, wherein the cartridge bodyfurther comprises a bottom surface defined opposite the deck, alongitudinal channel defined in the bottom surface, wherein at least aportion of the sled is slidably positioned in the longitudinal channel,and a retention portion configured to prevent the sled from falling outof the longitudinal channel through the bottom surface.

Example 4

The staple cartridge assembly of Example 3, wherein the sled is movablebetween a proximal position and a distal position during a firingstroke, wherein the retention portion is engaged with the sled when thesled is in the proximal position, and wherein the retention portion isnot engaged with the sled when the sled is in the distal position.

Example 5

The staple cartridge assembly of Examples 1, 2, 3, or 4, wherein thestaple cartridge assembly does not comprise a cover extending around thebottom surface of the cartridge body.

Example 6

The staple cartridge assembly of Examples 1, 2, 3, 4, or 5, wherein thecartridge body comprises at least one snap-fit feature configured todirectly engage the surgical stapler.

Example 7

The staple cartridge assembly of Examples 3, 4, or 5, wherein the sleddirectly engages the staples, and wherein the staple cartridge assemblydoes not comprise drivers positioned intermediate the sled and thestaples.

Example 8

The staple cartridge assembly of Examples 1, 2, 3, 4, 5, 6, or 7,wherein each staple is stamped from a sheet of material, wherein theproximal leg, the distal leg, and the base of each the staple are formedin a staple plane, and wherein the retention projection extendslaterally from the staple plane.

Example 9

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal end, a distal end, a deck, a bottom portion, a longitudinalslot defined in the deck extending from the proximal end toward thedistal end, a longitudinal channel defined in the bottom portion, andstaple cavities, wherein each staple cavity comprises a top openingdefined in the deck and a bottom opening defined in the bottom portion.The staple cartridge assembly further comprises staples removably storedin the staple cavities, a sled slidably positioned in the longitudinalchannel, wherein the sled is movable from the proximal end toward thedistal end to eject the staples through the top openings of the staplecavities, and a retention portion configured to prevent the sled fromfalling out of the longitudinal channel through the bottom portion.

Example 10

The staple cartridge assembly of Example 9, wherein the sled is movablebetween a proximal position and a distal position during a firingstroke, wherein the retention portion is engaged with the sled when thesled is in the proximal position, and wherein the retention portion isnot engaged with the sled when the sled is in the distal position.

Example 11

The staple cartridge assembly of Examples 9 or 10, wherein the staplecartridge assembly does not comprise a cover extending around the bottomportion of the cartridge body.

Example 12

The staple cartridge assembly of Examples 9, 10, or 11, wherein the sleddirectly engages the staples, and wherein the staple cartridge assemblydoes not comprise drivers positioned intermediate the sled and thestaples.

Example 13

A staple cartridge assembly for use with a surgical stapler, wherein thesurgical stapler includes a jaw configured to receive the staplecartridge assembly, and wherein the staple cartridge assembly comprisesa cartridge body including a proximal end, a distal end, a deck, abottom portion, wherein the staple cartridge assembly does not comprisean enclosure extending around the bottom portion, a longitudinal slotdefined in the deck extending from the proximal end toward the distalend, a longitudinal channel defined in the bottom portion, and staplecavities, wherein each the staple cavity comprises a top opening definedin the deck and a bottom opening defined in the bottom portion. Thestaple cartridge assembly further comprises staples removably stored inthe staple cavities, a sled slidably positioned in the longitudinalchannel, wherein the sled is movable from the proximal end toward thedistal end to eject the staples through the top openings of the staplecavities during a firing stroke, and means for preventing the sled fromfalling out of the longitudinal channel through the bottom portion.

Example 14

The staple cartridge assembly of Example 13, wherein the sled directlyengages the staples during the firing stroke.

Example 15

The staple cartridge assembly of Examples 13 or 14, further comprisingmeans for preventing the staples from falling out of the staple cavitiesthrough the bottom openings.

Example 16

A staple cartridge assembly for use with a surgical stapler, wherein thesurgical stapler includes a jaw configured to receive the staplecartridge assembly, and wherein the staple cartridge assembly comprisesa cartridge body including a proximal end, a distal end, a deck, abottom portion, wherein the staple cartridge assembly does not comprisean enclosure extending around the bottom portion, and staple cavities,wherein each the staple cavity comprises a top opening defined in thedeck and a bottom opening defined in the bottom portion. The staplecartridge assembly further comprises staples removably stored in thestaple cavities, wherein the cartridge body includes shelves integrallyformed with the cartridge body that prevent the staples from falling outof the staple cavities through the bottom openings.

Example 17

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal end, a distal end, a deck, a longitudinal slot defined in thedeck extending from the proximal end toward the distal end, and a staplecavity. The staple cavity comprises a top opening defined in the deck, abottom opening, a proximal guide, a distal guide, a sidewall extendingbetween the proximal guide and the distal guide, and an intermediateguide extending inwardly from the sidewall. The staple cartridgeassembly further comprises a staple removably stored in the staplecavity including a proximal leg positioned within the proximal guide, adistal leg positioned within the distal guide, and a base extendingbetween the proximal leg and the distal leg, wherein the intermediateguide is positioned to guide the base and hold the proximal leg in theproximal guide and the distal leg in the distal guide.

Example 18

The staple cartridge assembly of Example 17, wherein the staple cavityfurther comprises a proximal cavity end proximal to the proximal guideand a distal cavity end distal to the distal guide.

Example 19

The staple cartridge assembly of Example 18, wherein the staple is notpositioned in the proximal cavity end and the distal cavity end.

Example 20

The staple cartridge assembly of Examples 18 or 19, wherein a firstclearance gap is present between the staple base, the intermediateguide, and the distal cavity end, and wherein a second clearance gap ispresent between the staple base, the intermediate guide, and theproximal cavity end.

Example 21

The staple cartridge assembly of Examples 17, 18, 19, or 20, wherein thebase comprises a flat guide surface interfaced with the intermediateguide.

Example 22

The staple cartridge assembly of Examples 17, 18, 19, 20, or 21, whereinthe cartridge body further comprises a plurality of the staple cavities,and wherein the staple cartridge assembly further comprises a pluralityof the staples positioned in the staple cavities.

Example 23

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, or 22,wherein the proximal guide, the distal guide, and the intermediate guidetriangulate the control of the staple as the staple is ejected from thestaple cavity.

Example 24

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22 or 23,wherein the proximal guide and the distal guide extend above the deck.

Example 25

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22, 23, or24, wherein the intermediate guide extends above the deck.

Example 26

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22, 23,24, or 25, wherein the proximal leg and the distal leg of the stapledefine a leg plane, wherein the base comprises a drive surface in adrive plane, and wherein the drive plane is offset from the leg plane.

Example 27

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22, 23,24, 25, or 26, wherein the proximal leg and the distal leg are pinchedtoward each other by the proximal guide and the distal guide.

Example 28

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22, 23,24, 25, 26, or 27, wherein the intermediate guide comprises a resilientbiasing member engaged with the base configured to push the proximal leginto the proximal guide and the distal leg into the distal guide.

Example 29

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, or 28, wherein the intermediate guide is positionedcloser to the distal guide than the proximal guide.

Example 30

The staple cartridge assembly of Examples 17, 18, 19, 20, 21, 22, 23,24, 25, 26, 27, or 28, wherein the intermediate guide is positionedequidistant between the distal guide and the proximal guide.

Example 31

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal end, a distal end, a deck, a longitudinal slot defined in thedeck extending from the proximal end toward the distal end, and a staplecavity. The staple cavity comprises a top opening defined in the deck, abottom opening, a proximal guide, a distal guide, and a sidewallextending between the proximal guide and the distal guide. The staplecartridge assembly further comprises a staple removably stored in thestaple cavity including a proximal leg positioned within the proximalguide, a distal leg positioned within the distal guide, wherein theproximal leg and the distal leg define a leg plane, and wherein theproximal leg and the distal leg are pinched toward each other by theproximal guide and the distal guide, and a base extending between theproximal leg and the distal leg, wherein the base comprises a drivesurface in a drive plane, and wherein the drive plane is offset from theleg plane.

Example 32

The staple cartridge assembly of Example 31, wherein the leg plane isparallel to the drive plane.

Example 33

The staple cartridge assembly of Examples 31 or 32, wherein thecartridge body further comprises a plurality of the staple cavities, andwherein the staple cartridge assembly further comprises a plurality ofthe staples positioned in the staple cavities.

Example 34

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal end, a distal end, a deck, a longitudinal slot defined in thedeck extending from the proximal end toward the distal end, and a staplecavity. The staple cavity comprises a top opening defined in the deck, abottom opening, a proximal guide, a distal guide, a sidewall extendingbetween the proximal guide and the distal end guide, and an intermediateguide extending inwardly from the staple cavity sidewall. The staplecartridge assembly further comprises a staple removably stored in thestaple cavity including a proximal leg positioned within the proximalguide, a distal leg positioned within the distal guide, and a baseextending between the proximal leg and the distal leg, wherein theproximal guide, the distal guide, and the intermediate guide triangulatethe control of the staple as the staple is ejected from the staplecavity.

Example 35

The staple cartridge assembly of Example 34, wherein the cartridge bodyfurther comprises a plurality of the staple cavities, and wherein thestaple cartridge assembly further comprises a plurality of the staplespositioned in the staple cavities.

Example 36

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal cartridge end, a distal cartridge end, a deck, a longitudinalknife slot defined in the deck extending from the proximal cartridge endtoward the distal cartridge end, and a staple cavity. The staple cavitycomprises a top opening defined in the deck, a proximal cavity end, adistal cavity end, a proximal guide, a distal guide, wherein theproximal guide and the distal guide extend above the deck, and a cavityslot extending between the proximal cavity end and the distal cavityend, wherein the proximal guide and the distal guide extend laterallywith respect to the cavity slot. The staple cartridge assembly furthercomprises a staple removably stored in the staple cavity including aproximal leg positioned within the proximal guide, a distal legpositioned within the distal guide, and a base extending between theproximal leg and the distal leg, wherein the base is positioned in thecavity slot.

Example 37

The staple cartridge assembly of Example 36, wherein the proximal guideand the distal guide extend toward the knife slot.

Example 38

The staple cartridge assembly of Example 36, wherein the proximal guideand the distal guide extend away from the knife slot.

Example 39

The staple cartridge assembly of Examples 36, 37, or 38, wherein theproximal guide comprises a proximal bracket.

Example 40

The staple cartridge assembly of Example 39, wherein the proximalbracket does not extend around the proximal cavity end.

Example 41

The staple cartridge assembly of Examples 39 or 40, wherein the cavityslot is defined by a longitudinal axis, and wherein the proximal bracketis not aligned with the longitudinal axis.

Example 42

The staple cartridge assembly of Examples 36, 37, 38, 39, 40, or 41,wherein the distal guide comprises a distal bracket.

Example 43

The staple cartridge assembly of Example 42, wherein the distal bracketdoes not extend around the distal cavity end.

Example 44

The staple cartridge assembly of Examples 42 or 43, wherein the cavityslot is defined by a longitudinal axis, and wherein the distal bracketis not aligned with the longitudinal axis.

Example 45

The staple cartridge assembly of Examples 36, 37, 38, 39, 40, 41, 42,43, or 44, wherein the proximal leg and the distal leg define a stapleleg plane, wherein the base comprises a drive surface in a drive planeoffset from the staple leg plane, wherein the proximal guide and thedistal guide are aligned with the staple plane, and wherein the proximalguide and the distal guide are not aligned with the drive plane.

Example 46

The staple cartridge assembly of Examples 36, 37, 38, 39, 40, 41, 42,43, or 44, wherein the proximal leg and the distal leg define a stapleleg plane, wherein the base comprises a drive surface in a drive planeoffset from the staple leg plane, and wherein the proximal guide and thedistal guide define a bracket plane aligned with the staple leg plane.

Example 47

The staple cartridge assembly of Examples 36, 37, 38, 39, 40, 41, 42,43, 44, 45, or 46, wherein the cartridge body further comprises aplurality of the staple cavities, and wherein the staple cartridgeassembly further comprises a plurality of the staples positioned in thestaple cavities.

Example 48

The staple cartridge assembly of Examples 36, 37, 38, 39, 40, 41, 42,43, 44, 45, 46, or 47, wherein a portion of the proximal guide thatextends above the deck comprises a staple cavity extender, and wherein aportion of the distal guide that extends above the deck comprises astaple cavity extender

Example 49

A staple cartridge assembly for use with a surgical stapler, wherein thestaple cartridge assembly comprises a cartridge body including aproximal cartridge end, a distal cartridge end, a deck, and a staplecavity. The staple cavity includes a proximal cavity end, a distalcavity end, a proximal guide extending above and below the deck, adistal guide extending above and below the deck, and a connecting slotextending between the proximal cavity end and the distal cavity end,wherein the proximal guide and the distal guide extend laterally withrespect to the connecting slot. The staple cartridge assembly furthercomprises a staple removably stored in the staple cavity comprising aproximal leg positioned within the proximal guide, a distal legpositioned within the distal guide, and a base extending between theproximal leg and the distal leg, wherein the base is positioned in thecavity slot.

Example 50

The staple cartridge assembly of Example 49, wherein the cartridge bodyfurther comprises a plurality of the staple cavities, and wherein thestaple cartridge assembly further comprises a plurality of the staplespositioned in the staple cavities.

Example 51

The staple cartridge assembly of Examples 49 or 50, wherein the portionof the proximal guide that extends above the deck comprises a staplecavity extender, and wherein the portion of the distal guide thatextends above the deck comprises a staple cavity extender

Example 52

A fastener cartridge assembly for use with a surgical fasteninginstrument, wherein the fastener cartridge assembly comprises acartridge body comprising a proximal cartridge end, a distal cartridgeend, a deck, and a fastener pocket. The fastener pocket comprises aproximal pocket end, a distal pocket end, a proximal guide, a distalguide, a proximal pocket extender, wherein the proximal pocket extenderextends above the deck, a distal pocket extender, wherein the proximalpocket extender extends above the deck, and a pocket opening extendingbetween the proximal pocket end and the distal pocket end, wherein theproximal guide and the distal guide extend laterally with respect to thepocket opening. The fastener cartridge assembly further comprises afastener removably stored in the fastener pocket comprising a proximalleg positioned within the proximal guide, a distal leg positioned withinthe distal guide, and a base extending between the proximal leg and thedistal leg, wherein the base is positioned in the pocket opening.

Example 53

The fastener cartridge assembly of Example 52, wherein the cartridgebody further comprises a plurality of the fastener pockets, and whereinthe fastener cartridge assembly further comprises a plurality of thefasteners positioned in the fastener pockets.

Example 54

A staple cartridge assembly for use with a surgical instrument, thestaple cartridge assembly comprising a cartridge body including aproximal end, a distal end, a deck, and staple cavities defined in thedeck. The staple cartridge assembly further comprises staples removablypositioned in the staple cavities and a firing member comprising achannel aligned with the staples, wherein the channel comprises a firstlateral sidewall and a second lateral sidewall, and wherein the channelis configured to receive the staples between the first lateral sidewalland the second lateral sidewall.

Example 55

The staple cartridge assembly of Example 54, wherein the channel isdefined on an inclined surface of the firing member.

Example 56

The staple cartridge assembly of Examples 54 or 55, wherein the channelcomprises a ramp portion configured to lift the staples within thestaple cavities during a firing stroke of the firing member and an apexportion configured to form the staples against an anvil of the surgicalinstrument to a final formed height.

Example 57

The staple cartridge assembly of Example 56, wherein the channelcomprises a trailing portion positioned proximally with respect to theapex portion, and wherein the apex portion is positioned above thetrailing portion.

Example 58

The staple cartridge assembly of Examples 54, 55, 56, or 57, wherein thefiring member comprises a sled including a plurality of wedges, andwherein the channel is defined on one of the wedges.

Example 59

The staple cartridge assembly of Examples 54, 55, 56, 57, or 58, whereinthe firing member further comprises a ramp configured to initially liftthe staples within the staple cavities and guide the staples into thechannel.

Example 60

The staple cartridge assembly of Examples 54, 55, 56, 57, 58, or 59,wherein the channel comprises a mouth portion and a longitudinalportion, wherein the mouth portion provides a lead-in to thelongitudinal portion, and wherein the mouth portion is wider than thelongitudinal portion.

Example 61

The staple cartridge assembly of Examples 54, 55, 56, 57, 58, 59, or 60,wherein the staples are received within the channel without a stapledriver positioned between the staples and the channel.

Example 62

The staple cartridge assembly of Examples 54, 55, 56, 57, 58, 59, 60, or61, wherein the first lateral sidewall is parallel to the second lateralsidewall.

Example 63

The staple cartridge assembly of Examples 54, 55, 56, 57, 58, 59, 60, or61, wherein the first lateral sidewall is not parallel to the secondlateral sidewall.

Example 64

The staple cartridge assembly of Examples 54, 55, 56, 57, 58, 59, 60, or61, wherein the first lateral sidewall and the second lateral are angledwith respect to each other to create a staple entry lead-in.

Example 65

The staple cartridge assembly of Examples 54, 55, 56, 57, 58, 59, 60,61, 62, 63, or 64, wherein the channel comprises a first channel, andwherein the firing member further comprises a second channel configuredto receive the staples.

Example 66

The staple cartridge assembly of Example 65, wherein each staplecomprises a drive portion configured to enter the first channel, and aforming portion configured to enter the second channel.

Example 67

The staple cartridge assembly of Examples 65 or 66, wherein the firstchannel extends at an angle relative to the second channel.

Example 68

The staple cartridge assembly of Examples 65, 66, or 67, wherein thefirst channel and the second channel are parallel to one another in afirst region and non-parallel to one another in a second region.

Example 69

The staple cartridge assembly of Examples 65, 66, 67, or 68, wherein thesecond channel is configured to receive the staples before the firstchannel as the firing member is advanced toward the distal end.

Example 70

A staple cartridge assembly for use with a surgical instrument, thestaple cartridge assembly comprising a cartridge body comprising a deckand staple cavities defined in the deck, staples removably positioned inthe staple cavities, and a firing member comprising a ramp configured todirectly engage the staples and a rail extending from the rampconfigured to orient the staples relative to the ramp.

Example 71

The staple cartridge assembly of Example 70, wherein the rail comprisesa first rail, and wherein the firing member further comprises a secondrail extending from the ramp configured to orient the staples relativeto the ramp.

Example 72

The staple cartridge assembly of Example 71, wherein the first rail isparallel to the second rail.

Example 73

A staple cartridge assembly for use with a surgical stapling instrumentincluding an anvil, wherein the anvil includes forming pockets, andwherein the staple cartridge assembly comprises a cartridge bodycomprising a proximal end, a distal end, a deck, and staple cavitiesdefined in the deck. The staple cartridge assembly comprises staplesremovably positioned in the staple cavities, wherein each staplecomprises a staple driving portion and a staple forming portion, and afiring member comprising a first guide channel aligned with the stapledriving portions of the staples and a second guide channel aligned withthe staple forming portions of the staples, wherein the first guidechannel and the second guide channel are configured to co-operativelyalign the staples with the staple forming pockets of the anvil when thefiring member is moved toward the distal end.

Example 74

A staple cartridge assembly comprising a cartridge body including adeck, a first longitudinal row of staple cavities, and a secondlongitudinal row of staple cavities. The staple cartridge assemblyfurther comprises a plurality of first staples, wherein each firststaple is removably stored in the first longitudinal row of staplecavities, and wherein each first staple comprises a unitary structureincluding a first base including a first drive surface and a firststaple leg extending from the first base and including a first tip,wherein a first unformed distance is defined between the first drivesurface and the first tip, a plurality of second staples, wherein eachsecond staple is removably stored in the second longitudinal row ofstaple cavities, and wherein each second staple comprises a unitarystructure including a second base including a second drive surface and asecond staple leg extending from the second base and including a secondtip, wherein a second unformed distance is defined between the seconddrive surface and the second tip which is different than the firstunformed distance, and a firing member configured to directly engage thefirst staples and the second staples.

Example 75

The staple cartridge assembly of Example 74, wherein the first staplesand the second staples are formed from a sheet of metal.

Example 76

The staple cartridge assembly of Examples 74 or 75, wherein each firstbase includes a first tissue supporting surface, wherein a first tissuecapture distance is defined between the first tissue supporting surfaceand the first tip, wherein each second base includes a second tissuesupporting surface, wherein a second tissue capture distance is definedbetween the second tissue supporting surface and the second tip, andwherein the first tissue capture distance is different than the secondtissue capture distance.

Example 77

The staple cartridge assembly of Examples 74, 75, or 76, wherein thedeck comprises a first deck height along the first longitudinal row ofstaple cavities and a second deck height along second the longitudinalrow of staple cavities which is different than the first deck height.

Example 78

The staple cartridge assembly of Example 77, wherein the cartridge bodyfurther comprises a longitudinal slot configured to receive a cuttingmember, wherein the first longitudinal row of staple cavities isadjacent the longitudinal slot, wherein the second longitudinal row ofstaple cavities is adjacent the first longitudinal row of staplecavities, and wherein the second deck height is shorter than the firstdeck height.

Example 79

The staple cartridge assembly of Examples 74, 75, 76, 77, or 78, whereinthe cartridge body further comprises a longitudinal slot configured toreceive a cutting member, wherein the first longitudinal row of staplecavities is adjacent the longitudinal slot, and wherein the secondlongitudinal row of staple cavities is adjacent the first longitudinalrow of staple cavities.

Example 80

The staple cartridge assembly of Examples 74, 75, 76, 77, 78, or 79,wherein the first unformed distance is shorter than the second unformeddistance.

Example 81

The staple cartridge assembly of Examples 74, 75, 76, 77, 78, 79, or 80,further comprising an anvil configured to deform the staples.

Example 82

The staple cartridge assembly of Example 81, wherein the anvil isconfigured to deform the first staples to a first deformed height andthe second staples to a second deformed height which is different thanthe first deformed height.

Example 83

The staple cartridge assembly of Examples 81 or 82, wherein thecartridge body is movable toward the anvil to clamp tissue between theanvil and the deck of the cartridge body.

Example 84

The staple cartridge assembly of Examples 81, 82, or 83, wherein theanvil is movable toward the cartridge body to clamp tissue between theanvil and the deck of the cartridge body.

Example 85

The staple cartridge assembly of Examples 74, 75, 76, 77, 78, 79, 80,81, 82, 83, or 84, further comprising staple cavity extenders extendingfrom the deck.

Example 86

The staple cartridge assembly of Examples 74, 75, 76, 77, 78, 79, 80,81, 82, 83, 84, or 85, further comprising an implantable layerpositioned over the deck.

Example 87

A staple cartridge assembly comprising a cartridge body comprising adeck, a first longitudinal row of staple cavities, and a secondlongitudinal row of staple cavities. The staple cartridge assemblyfurther comprises a plurality of first staples, wherein each firststaple is removably stored in the first longitudinal row of staplecavities, and wherein each first staple comprises a unitary structureincluding a first base including a first drive surface and a firsttissue supporting surface and a first staple leg extending from thefirst base including a first tip, wherein a first tissue capturedistance is defined between the first tissue supporting surface and thefirst tip, a plurality of second staples, wherein each second staple isremovably stored in the second longitudinal row of staple cavities, andwherein each second staple comprises a unitary structure including asecond base including a second drive surface and a second tissuesupporting surface and a second staple leg extending from the secondbase including a second tip, wherein a second tissue capture distance isdefined between the second tissue supporting surface and the second tipwhich is different than the first tissue capture distance, and a firingmember configured to directly engage the first staples and the secondstaples.

Example 88

The staple cartridge assembly of Example 87, wherein the deck comprisesa first deck height along the first longitudinal row of staple cavitiesand a second deck height along second the longitudinal row of staplecavities which is different than the first deck height.

Example 89

The staple cartridge assembly of Example 88, wherein the cartridge bodyfurther comprises a longitudinal slot configured to receive a cuttingmember, wherein the first longitudinal row of staple cavities isadjacent the longitudinal slot, wherein the second longitudinal row ofstaple cavities is adjacent the first longitudinal row of staplecavities, and wherein the second deck height is shorter than the firstdeck height.

Example 90

The staple cartridge assembly of Examples 87, 88, or 89, furthercomprising an anvil configured to deform the staples.

Example 91

The staple cartridge assembly of Example 90, wherein the anvil isconfigured to deform the first staples to a first deformed height andthe second staples to a second deformed height which is different thanthe first deformed height.

Example 92

The staple cartridge assembly of Examples 90 or 91, wherein thecartridge body is movable toward the anvil to clamp tissue between theanvil and the deck of the cartridge body.

Example 93

A staple cartridge assembly comprising a cartridge body comprising afirst longitudinal row of staple cavities and a second longitudinal rowof staple cavities, a plurality of first staples removably stored in thefirst longitudinal row of staple cavities, wherein each first staple iscomprised of stamped metal and includes an integrally-formed metaldriver, a plurality of second staples removably stored in the secondlongitudinal row of staple cavities, wherein each second staple iscomprised of stamped metal and includes an integrally-formed metaldriver, and means for forming the first staples to a first deformedheight and the second staples to a second deformed height, wherein thefirst deformed height is different than the second deformed height.

Example 94

A staple cartridge assembly comprising a staple cartridge body includinga deck and staple cavities defined in the deck, staples removable storedin the staple cavities, wherein each staple comprises a base, a legextending from the base, and a platform extending laterally from thebase, and an implantable layer positioned over the deck, wherein theplatforms of the staples are configured to abut the layer when thestaples are implanted into the tissue of a patient.

Example 95

The staple cartridge assembly of Example 94, wherein each staple isstamped from a sheet of material, wherein the base defines a base plane,and wherein the platform is folded out of the base plane.

Example 96

The staple cartridge assembly of Examples 94 or 95, wherein theimplantable layer comprises a woven material.

Example 97

The staple cartridge assembly of Examples 94, 95, or 96, wherein theimplantable layer comprises a non-woven material.

Example 98

The staple cartridge assembly of Examples 94, 95, 96, or 97, furthercomprising a retention member extending from the leg adjacent the base,wherein the retention member is configured to engage the implantablelayer when staples are implanted into the tissue of a patient.

Example 99

The staple cartridge assembly of Examples 94, 95, 96, 97, or 98, whereinthe platform is flat.

Example 100

The staple cartridge assembly of Examples 94, 95, 96, 97 98, or 99,wherein the platform is not directly attached to the leg.

Example 101

A staple cartridge assembly comprising a staple cartridge body includinga deck and staple cavities defined in the deck, staples removable storedin the staple cavities, wherein each staple comprises a crown, a firstleg and a second leg extending from the crown, and a platform extendinglaterally from the crown, and an implantable layer positioned over thedeck, wherein the platforms of the staples are configured to support thelayer when the staples are implanted into the tissue of a patient.

Example 102

The staple cartridge assembly of Example 101, wherein each staple isstamped from a sheet of material, wherein the crown defines a crownplane, and wherein the platform is folded out of the crown plane.

Example 103

The staple cartridge assembly of Examples 101 or 102, wherein theimplantable layer comprises a woven material.

Example 104

The staple cartridge assembly of Examples 101, 102, or 103, wherein theimplantable layer comprises a non-woven material.

Example 105

The staple cartridge assembly of Examples 101, 102, 103, or 104, furthercomprising a retention member extending from the leg adjacent the crown,wherein the retention member is configured to engage the implantablelayer when staples are implanted into the tissue of a patient.

Example 106

The staple cartridge assembly of Examples 101, 102, 103, 104, or 105,wherein the platform is flat.

Example 107

The staple cartridge assembly of Examples 101, 102, 103, 104, 105, or106, wherein each staple comprises a compliant adjunct positionedadjacent the crown.

Example 108

The staple cartridge assembly of Example 107, wherein the compliantadjunct extends between the first leg and the second leg.

Example 109

The staple cartridge assembly of Examples 107 or 108, wherein thecompliant adjunct is attached to the first leg and the second leg.

Example 110

The staple cartridge assembly of Examples 107, 108, or 109, wherein thecompliant adjunct comprises a first aperture and a second aperture,wherein the first leg extends through the first aperture, and whereinthe second leg extends through the second aperture.

Example 111

The staple cartridge assembly of Examples 107, 108, 109, or 110, whereinthe compliant adjunct comprises a cavity and at least one medicamentpositioned in the cavity.

Example 112

The staple cartridge assembly of Examples 107, 108, 109, 110, or 111,wherein the compliant adjunct comprises a compressible enclosure.

Example 113

A staple cartridge assembly comprising a staple cartridge body includinga deck and staple cavities defined in the deck, and staples removablystored in the staple cavities, wherein each staple comprises a crown, afirst leg and a second leg extending from the crown, a platformextending laterally from the crown, and a compliant adjunct positionedadjacent the crown.

Example 114

The staple cartridge assembly of Example 113, wherein the compliantadjunct extends between the first leg and the second leg.

Example 115

The staple cartridge assembly of Examples 113 or 114, wherein thecompliant adjunct is attached to the first leg and the second leg.

Example 116

The staple cartridge assembly of Examples 113, 114, or 115, wherein thecompliant adjunct comprises a first aperture and a second aperture,wherein the first leg extends through the first aperture, and whereinthe second leg extends through the second aperture.

Example 117

The staple cartridge assembly of Examples 113, 114, 115, or 116, whereinthe compliant adjunct comprises a cavity and at least one medicamentpositioned in the cavity.

Example 118

The staple cartridge assembly of Examples 113, 114, 115, 116, or 117,wherein the compliant adjunct comprises a compressible enclosure.

Example 119

A staple cartridge assembly comprising a cartridge body including a deckand a plurality of staple cavities defined in the deck, and a pluralityof staples stored in the staple cavities, wherein each staple comprisesa first portion comprised of an alloy including zinc and magnesium and asecond portion comprised of an absorbable polymer, wherein the secondportion is disposed on the first portion, and wherein the second portioncovers less than the entirety of the first portion.

Example 120

The staple cartridge assembly of Example 119, wherein the first portioncomprises a base and a staple leg extending from the base, and whereinthe second portion extends around the staple leg in a spiral pattern.

Example 121

The staple cartridge assembly of Examples 119 or 120, wherein the secondportion is coated on the first portion in a dot-matrix pattern.

Example 122

The staple cartridge assembly of Examples 119, 120, or 121, wherein thefirst portion comprises a base and a staple leg extending from the base,wherein a corner is defined between the base and the staple leg, andwherein the second portion covers the corner.

Example 123

The staple cartridge assembly of Examples 119, 120, 121, or 122, whereinthe absorbable polymer comprises a non-crosslinked polymer.

Example 124

The staple cartridge assembly of Examples 119, 120, 121, 122, or 123,wherein the second portion is coated on the first portion in a meshpattern.

Example 125

The staple cartridge assembly of Examples 119, 120, 121, 122, 123, or124, wherein the first portion comprises a base and a staple legextending from the base, wherein the staple leg comprises a tissuepenetrating tip, and wherein the staple further comprises magnesiumnitride disposed on the tip.

Example 126

The staple cartridge assembly of Examples 119, 120, 121, 122, 123, 124,or 125, wherein the staple further comprises a coating of ionized silveron at least part of the first portion that is not coated by the secondportion.

Example 127

The staple cartridge assembly of Examples 119, 120, 121, 122, 123, 124,125, or 126, further comprising at least one aperture in the firstportion.

Example 128

A staple cartridge assembly comprising a cartridge body including a deckand a plurality of staple cavities defined in the deck and a pluralityof staples stored in the staple cavities, wherein each staple comprisesa metal frame comprised of a magnesium alloy and an absorbable polymercoated on the metal frame, wherein the absorbable polymer does not coverevery portion of the metal frame.

Example 129

A staple cartridge assembly comprising a cartridge body including a deckand a plurality of staple cavities defined in the deck, and a pluralityof staples stored in the staple cavities, wherein each staple comprisesa metal frame comprised of a magnesium alloy, wherein the metal framecomprises a base and a leg extending from the base, and wherein the legcomprises a tissue penetrating tip, and a magnesium nitride coating onthe tip.

Example 130

The staple cartridge assembly of Example 129, wherein each staplefurther comprises an absorbable polymer coated on the metal frame, andwherein the absorbable polymer does not cover every portion of the metalframe.

Example 131

The staple cartridge assembly of Examples 129 or 130, wherein eachstaple further comprises a coating comprising silver on at least aportion of the metal frame.

Example 132

A staple cartridge assembly comprising a cartridge body including a deckand a plurality of staple cavities defined in the deck, and a pluralityof staples stored in the staple cavities, wherein each staple comprisesa metal frame comprised of a magnesium alloy, wherein the metal framecomprises a base and a leg extending from the base, and wherein the legcomprises a tissue penetrating tip, and a coating comprising silver onat least a portion of the metal frame.

Example 133

The staple cartridge assembly of Example 132, wherein each staplefurther comprises an absorbable polymer coated on the metal frame, andwherein the absorbable polymer does not cover every portion of the metalframe.

Example 134

The staple cartridge assembly of Examples 132 or 133, further comprisinga magnesium nitride coating on the tip.

Example 135

A staple cartridge assembly comprising a cartridge body including a deckand a plurality of staple cavities defined in the deck, and a pluralityof staples stored in the staple cavities, wherein each staple comprisesa metal frame comprised of a magnesium alloy, wherein the metal framecomprises a base and a leg extending from the base, and wherein the legcomprises tissue penetrating tip, and an aperture defined in the metalframe.

Example 136

The staple cartridge assembly of Example 135, wherein each staplefurther comprises an absorbable polymer coated on the metal frame, andwherein the absorbable polymer does not cover every portion of the metalframe.

Example 137

The staple cartridge assembly of Example 135, wherein each staplefurther comprises an absorbable polymer coated on the metal frame, andwherein the absorbable polymer is not positioned in the aperture.

Example 138

The staple cartridge assembly of Example 135, wherein each staplefurther comprises an absorbable polymer coated on the metal frame, andwherein the absorbable polymer is positioned in the aperture.

Example 139

The staple cartridge assembly of Example 135, wherein each staplefurther comprises an absorbable polymer coated on the metal frame, andwherein the aperture is filled with the absorbable polymer.

Example 140

A staple cartridge assembly for stapling tissue comprising a cartridgebody including a proximal end, a distal end, and a plurality of staplecavities, a plurality of staples positioned in the staple cavities,wherein each staple comprises a base a leg extending from the base,wherein the leg comprises a tip configured to penetrate the tissue, anda foot extending from the base, and a firing member configured to ejectthe staples from the staple cavities, wherein the firing member isconfigured to contact the foot of any staple that is misoriented withinits staple cavity prior to ejecting the misoriented staple from itsstaple cavity.

Example 141

The staple cartridge assembly of Example 140, wherein the firing membercomprises a firing ramp configured to contact the bases of the staplesto drive the staples out of the staple cavities and an alignment rampconfigured to contact the feet of the staples if the staples aremisoriented.

Example 142

The staple cartridge assembly of Examples 140 or 141, wherein the firingmember further comprises a firing channel aligned with the firing ramp,wherein the firing channel is configured to receive the bases of thestaples, and an alignment channel aligned with the alignment ramp,wherein the alignment channel is configured to receive the feet of thestaples once the staples are properly oriented.

Example 143

The staple cartridge assembly of Examples 141 or 142, wherein thealignment ramp extends distally with respect to the firing ramp suchthat the alignment ramp can contact the feet of the staples before thefiring ramp contacts the bases of the staples.

Example 144

The staple cartridge assembly of Examples 140, 141, 142, or 143, whereinthe foot of the staple is positioned proximally with respect to the baseof the staple.

Example 145

The staple cartridge assembly of Examples 140, 141, 142, 143, or 144,wherein the firing member is not configured to contact the feet of thestaples if the staples are properly oriented within the staple cavities.

Example 146

A staple cartridge assembly for stapling tissue comprising a cartridgebody comprising a proximal end and a distal end, and a plurality ofstaple cavities, wherein each staple cavity comprises a top opening, aproximal wall, and a distal wall. The staple cartridge assembly furthercomprises a firing member and a plurality of staples positioned in thestaple cavities, wherein each staple comprises a base, a proximal legextending from the base, a distal leg extending from the base, andcenter of mass defined in the base, wherein the distal wall provides adistal reaction force to the staple above the center of mass and theproximal wall provides a proximal reaction force to the staple below thecenter of mass wherein the staple is lifted toward the top opening bythe firing member. The staple cartridge assembly further comprises afiring member configured to eject the staples from the staple cavities,wherein the firing member is configured to contact the foot of anystaple that is misoriented within its staple cavity prior to ejectingthe misoriented staple from its staple cavity.

Example 147

The staple cartridge assembly of Example 146, wherein the base defines adrive plane, and wherein the proximal leg and the distal leg are not inthe drive plane.

Example 148

The staple cartridge assembly of Examples 146 or 147, wherein theproximal leg and the distal leg are offset laterally from the center ofmass of the staple.

Example 149

The staple cartridge assembly of Examples 146, 147, or 148, wherein thedistal wall applies the distal reaction force to the distal leg and theproximal wall applies the proximal reaction force to the proximal leg.

Example 150

The staple cartridge assembly of Example 147, wherein the proximal legextends to a first side of the drive plane and the distal leg extends toa second side of the drive plane.

Example 151

The staple cartridge assembly of Examples 146, 147, 148, 149, or 150,wherein the base comprises a notch defined therein configured to shiftthe center of mass of the staple toward a side of the staple cavity.

Example 152

A staple cartridge assembly for stapling tissue comprising a cartridgebody including a proximal end, a distal end, and a plurality of staplecavities. The staple cartridge assembly further comprises a plurality ofstaples positioned in the staple cavities, wherein each staple comprisesa base defining a drive plane and a leg extending from the base, whereinthe leg extends to a side of the drive plane, a firing member configuredto eject the staples from the staple cavities, and means for reducingthe rotation of the staples within the staple cavities when the firingmember is driving the staples out of the staple cavities.

Example 153

A surgical staple cartridge for use with a surgical stapling instrument,the surgical staple cartridge comprising a cartridge body, a pluralityof staple cavities, and a plurality of staples removably stored in thestaple cavities, wherein each staple comprises a staple base portionwhich defines a first plane, a center of mass located within the staplebase portion, a first staple leg extending from the staple base portion,and a second staple leg extending from the staple base portion, whereinthe first staple leg and the second staple leg define a second planewhich is offset and at least substantially parallel to the first plane.

Example 154

The surgical staple cartridge of Example 153, wherein the first stapleleg and the second staple leg are configured to form toward the staplebase portion.

Example 155

The surgical staple cartridge of Examples 153 or 154, wherein the staplebase portion comprises a compression surface comprising a contourconfigured to limit tissue compression.

Example 156

The surgical staple cartridge of Examples 153, 154, or 155, wherein thestaple base portion comprises a bottom surface, and wherein the firststaple leg further comprises an engagement foot elevated above thebottom surface.

Example 157

The surgical staple cartridge of Examples 153, 154, 155, or 156, whereinthe staple base portion comprises an inner wall and a top surface,wherein the inner wall and the top surface comprise a cutout configuredto cause the staple base portion to lean toward the staple legs.

Example 158

The surgical staple cartridge of Examples 153, 154, 155, 156, or 157,wherein the first staple leg extends higher than the second staple leg.

Example 159

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, or158, wherein the staple base portion comprises a rectangularcross-sectional profile.

Example 160

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,or 159, wherein the first staple leg and the second staple leg comprisea substantially round cross-sectional profile.

Example 161

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,159, or 160, wherein the first staple leg and the second staple legcomprise coined corners.

Example 162

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,159, 160, or 161, wherein the first staple leg is proximal the secondstaple leg, wherein the staple base portion comprises a distal wall, andwherein the distal wall is proximal to the second staple leg.

Example 163

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,159, 160, 161, or 162, wherein the first staple leg comprises a firstheight and the second staple leg comprises a second height differentthan the first height.

Example 164

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,159, 160, 161, 162, or 163, wherein the first staple leg and the secondstaple leg each comprise a staple tip configured to form againstcorresponding forming pockets of an anvil, wherein the correspondingforming pockets comprise a valley and a forming surface, and wherein thevalley is configured to funnel the staple tips toward the formingsurface.

Example 165

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,159, 160, 161, 162, 163, or 164, wherein the first staple leg and thesecond staple leg are configured to form against corresponding formingpockets, wherein the corresponding forming pockets are configured toform the first staple leg in a first direction and the second staple legin a second direction, and wherein the first direction is opposite andat least substantially parallel to the second direction.

Example 166

The surgical staple cartridge of Example 165, wherein the firstdirection points away from the staple base portion, and wherein thesecond direction points toward the staple base portion.

Example 167

The surgical staple cartridge of Examples 153, 154, 155, 156, 157, 158,159, 160, 161, 162, 163, 164, 165, or 166, wherein the first staple legand the second staple leg are configured to form against correspondingforming pockets, wherein the corresponding forming pockets areconfigured to form the first staple leg in a first curved direction andthe second staple leg in a second curved direction.

Example 168

A surgical staple comprising a staple base portion defining a firstplane, a first staple leg extending at least substantially perpendicularfrom the staple base portion, and a second staple leg extending at leastsubstantially perpendicular from the staple base portion, wherein thefirst staple leg and the second staple leg define a second plane,wherein the first plane and the second plane intersect.

Example 169

A surgical staple cartridge comprising a plurality of the surgicalstaple of Examples 152, 153, 154, 155, 156, 157, 158, 159, 160, 161,162, 163, 164, 165, 166, 167, or 168, wherein the surgical staples arearranged in a plurality of woven rows.

Example 170

The surgical staple of Examples 168 or 169, wherein the staple isconfigured to form into an S-shape configuration.

Example 171

A surgical staple comprising a staple base portion comprising a bottomsurface which defines a bottom plane, a center of mass located withinthe staple base portion, and a first staple leg and a second staple legextending from the staple base portion and defining a staple leg planewhich is offset and at least substantially parallel to the staple baseportion, wherein the first staple leg comprises an engagement footelevated above the bottom plane.

Example 172

The surgical staple of Example 171, wherein the engagement foot islaterally offset with respect to the staple base portion.

Example 173

A surgical staple cartridge for use with a surgical stapler including ananvil to staple tissue, wherein the anvil comprises a plurality offorming pockets, the surgical staple cartridge comprising a cartridgebody, a plurality of staple cavities, and a plurality of staplesremovably stored within the staple cavities, wherein each staplecomprises a base and a staple leg extending from the base, wherein thestaple leg comprises a staple tip comprising a piercing portion, whereinthe piercing portion is configured to puncture tissue and deform againstthe forming pocket of the anvil, and wherein the piercing portion isconfigured to deform into a nested configuration such that the piercingtip is isolated from the tissue.

Example 174

The surgical staple cartridge of Example 173, wherein the nestedconfiguration comprises a hook configuration configured to prevent thesurgical staple from pulling through the tissue.

Example 175

The surgical staple cartridge of Examples 173 or 174, wherein the stapletip further comprises a cutout portion configured to receive thepiercing portion when the piercing portion is deformed.

Example 176

The surgical staple cartridge of Example 175, wherein the cutout portionis concave.

Example 177

The surgical staple cartridge of Examples 175 or 176, wherein eachstaple comprises another staple leg extending from the base, wherein theanother staple leg comprises another staple tip comprising anothercutout portion, and wherein the cutout portion and the another cutoutportion face each other.

Example 178

The surgical staple cartridge of Examples 173, 174, 175, 176, or 177,wherein the staple tip further comprises a curling surface configured toride against a corresponding forming pocket of the anvil.

Example 179

The surgical staple cartridge of Examples 173, 174, 175, 176, 177, or178, wherein each staple comprises another staple leg, wherein thestaple leg and the another staple leg define a first plane, wherein thestaple base defines a second plane, and wherein the first plane and thesecond plane are laterally offset from each other.

Example 180

A surgical staple for use with a surgical stapler including an anvil,wherein the anvil comprises a forming pocket, the surgical staplecomprising a staple base portion and a staple leg extending from thestaple base portion, wherein the staple leg comprises a staple tip, andwherein the staple tip comprises a piercing tip configured to contactthe forming pocket to deform the staple leg and a cutout portion,wherein the piercing tip is configured to curl in toward the cutoutportion upon contact with the forming pocket such that the staple tipassumes a non-piercing configuration.

Example 181

The surgical staple of Example 180, wherein the non-piercingconfiguration comprises a hook configuration configured to prevent thesurgical staple from pulling through the tissue.

Example 182

The surgical staple of Examples 180 or 181, wherein the cutout portionis configured to receive the piercing tip when the staple tip isdeformed.

Example 183

The surgical staple of Examples 180, 181, or 182, wherein the cutoutportion is concave.

Example 184

The surgical staple of Examples 180, 181, 182, or 183, wherein thestaple tip further comprises a deformable surface configured to formagainst the forming pocket of the anvil.

Example 185

A surgical staple cartridge for use with a surgical stapler including ananvil, the surgical staple cartridge comprising a cartridge body, aplurality of staple cavities, and a plurality of flat-formed staplesremovably stored within the staple cavities, wherein each staplecomprises a staple base portion and a staple leg extending from the baseportion, wherein the staple leg comprises a staple tip comprising arounded profile and a piercing portion.

Example 186

The surgical staple cartridge of Example 185, wherein the roundedprofile is attained by a cold working process.

Example 187

The surgical staple cartridge of Examples 185 or 186, wherein the stapletip comprises a coined portion.

Example 188

The surgical staple cartridge of Examples 185, 186, or 187, wherein thestaple tip further comprises a deformable surface configured to formagainst a forming pocket of the anvil.

Example 189

The surgical staple cartridge of Examples 185, 186, 187, or 188, whereinthe staple tip comprises a first hardness, and wherein the staple legcomprises a second hardness different than the first hardness.

Example 190

The surgical staple cartridge of Example 189, wherein the first hardnessis greater than the second hardness.

Example 191

A surgical staple cartridge for use with a surgical stapling instrument,the surgical staple cartridge comprising a cartridge body, a pluralityof staple cavities, and a plurality of staples removably stored withinthe staple cavities, wherein each staple comprises a staple base and apair of staple legs extending from the staple base, wherein each stapleleg comprises a staple tip, wherein the staple legs comprise a firstzone comprising a first hardness, and wherein the staple tips comprise asecond zone comprising a second hardness which is different than thefirst hardness.

Example 192

The surgical staple cartridge of Example 191, wherein the secondhardness is greater than the first hardness.

Example 193

The surgical staple cartridge of Example 191, wherein the secondhardness is less than the first hardness.

Example 194

The surgical staple cartridge of Examples 191, 192, or 193, wherein thestaple base comprises a third zone comprising a third hardness differentthan the first hardness and the second hardness.

Example 195

The surgical staple cartridge of Examples 191, 192, 193, or 194, whereinthe staple legs comprise corner portions that are coined to the firsthardness.

Example 196

The surgical staple cartridge of Example 195, wherein the cornerportions provide a preferential bending plane.

Example 197

The surgical staple cartridge of Examples 191, 192, 193, 194, 195, or196, wherein the first zone comprises a first ductility, and wherein thesecond zone comprises a second ductility which is less than the firstductility.

Example 198

A surgical staple cartridge for use with a surgical stapling instrument,the surgical staple cartridge comprising a cartridge body, a pluralityof staple cavities, and a plurality of staples removably stored withinthe staple cavities, wherein each staple comprises a staple base, a pairof staple legs extending from the staple base, a first zone comprising afirst hardness, and a second zone comprising a second hardness which isdifferent that the first hardness.

Example 199

The surgical staple cartridge of Example 198, wherein the first zone ishardened using a first method and the second zone is hardened using asecond method different than the first method.

Example 200

The surgical staple cartridge of Example 198, wherein only one of thefirst zone and the second zone is hardened by a hardening method.

Example 201

The surgical staple cartridge of Examples 198, 199, or 200, wherein eachstaple further comprises bend portions intermediate the staple legs andthe staple base, and wherein the bend portions comprise the first zoneand the staple base comprises the second zone.

Example 202

The surgical staple cartridge of Examples 198, 199, 200, or 201, whereinthe staple base comprises the first zone and the staple legs comprisethe second zone.

Example 203

The surgical staple cartridge of Examples 198, 199, 200, 201, or 202,wherein the staple legs are not hardened and the staple base is hardenedsuch that the staple legs are encouraged to assume a formedconfiguration and such that the staple base is configured to avoidplastic deformation.

Example 204

The surgical staple cartridge of Examples 198, 199, 200, 201, 202, or203, wherein each staple leg comprises a transition portion extendingfrom the staple base and a vertical leg portion extending from thetransition portion, and wherein the staple base comprises the first zoneand the vertical leg portion comprises the second zone.

Example 205

A surgical staple configured to be removably stored within a surgicalstaple cartridge in an unfired configuration, the surgical staplecomprising a non-uniform hardness profile, wherein the staple comprisesa first zone having a first hardness and a second zone having a secondhardness, wherein the first zone is hardened to the first hardness whenthe staple is in a pre-load configuration, and wherein the second zoneis hardened to the second hardness when the staple is in the pre-loadconfiguration.

Example 206

A surgical staple cartridge for use with a surgical stapling instrument,the surgical staple cartridge comprising a cartridge body, a pluralityof staple cavities, and a plurality of staples removably stored withinthe staple cavities, wherein each staple comprises a staple base,wherein the staple base defines a first zone comprising a firsthardness, a plurality of bend portions extending from the staple base,wherein the bend portions define a second zone comprising a secondhardness, and staple legs extending from the bend portions, wherein eachstaple leg defines a third zone comprising a third hardness differentthan the first hardness.

Example 207

The surgical staple cartridge of Example 206, wherein the first hardnessis greater than the third hardness.

Example 208

The surgical staple cartridge of Example 206, wherein the first hardnessis greater than the second hardness and the third hardness.

Example 209

The surgical staple cartridge of Examples 206, 207, or 208, wherein eachstaple leg comprises a staple tip defining a fourth zone comprising afourth hardness which is less than the third hardness.

Example 210

A surgical staple cartridge for use with a surgical stapling instrument,the surgical staple cartridge comprising a sled, a cartridge body, aplurality of staple cavities, and a strip of staples removably storedwithin the staple cavities, wherein the strip of staples comprises aplurality of staples, a strip, and a plurality of connector portionsjoining the staples to the strip, wherein the connector portions areconfigured to release the staples from the strip.

Example 211

The surgical staple cartridge of Example 210, wherein each connectorportion comprises a discontinuity configured to encourage the separationof the staples from the strip.

Example 212

The surgical staple cartridge of Example 210, wherein each connectorportion comprises a discontinuity configured to encourage the separationof the staple from the strip when the strip of staples is loaded intothe cartridge body.

Example 213

The surgical staple cartridge of Examples 210 or 211, wherein the sledis configured to separate the plurality of staples from the strip bybreaking the connector portions when the sled is translated through thestaple cartridge.

Example 214

The surgical staple cartridge of Examples 210, 211, 212, or 213, whereineach staple comprises a pair of outwardly biasing staple legs configuredto engage the cartridge body and hold the strip of staples in thesurgical staple cartridge.

Example 215

The surgical staple cartridge of Examples 210, 211, 212, 213, or 214,wherein the cartridge body comprises a bottom, and wherein the strip ofstaples is configured to be loaded into the bottom of the cartridgebody.

Example 216

The surgical staple cartridge of Examples 210, 211, 212, 213, 214, or215, wherein the plurality of staples are arranged in a first row and asecond row, and wherein the strip is joined to the staples in the firstrow and the second row.

Example 217

The surgical staple cartridge of Examples 210, 211, 212, 213, 214, 215,or 216, wherein the plurality of staples comprises a first group ofstaples having a first configuration and a second group of stapleshaving a second configuration different than the first configuration.

Example 218

The surgical staple cartridge of Examples 210, 211, 212, 213, 214, 215,216, or 217, wherein the connector portion comprises a peened portion.

Example 219

The surgical staple cartridge of Examples 210, 211, 212, 213, 214, 215,216, 217, or 218, wherein the sled comprises striking portionsconfigured to break the connector portions.

Example 220

The surgical staple cartridge of Examples 210, 211, 212, 213, 214, 215,216, 217, 218, or 219, wherein the staples comprise a chamfered surfaceconfigured to engage the sled when the sled is translated through thecartridge body.

Example 221

The surgical staple cartridge of Examples 210, 211, 212, 213, 214, 215,216, 217, 218, 219, or 220, wherein the strip comprise alignmentfeatures configured to engage corresponding alignment features on thecartridge body.

Example 222

A surgical staple cartridge for use with a surgical stapling instrument,the surgical staple cartridge comprising a cartridge body, a pluralityof staple cavities, and a strip of staples removably stored within thecartridge body, the strip of staples comprising a plurality of staples,a strip, and a plurality of connector portions joining the staples tothe strip, wherein the connector portions are engageable to release thestaples from the strip, and wherein the staples, the strip, and theconnector portions are metal.

Example 223

The surgical staple cartridge of Example 222, wherein the plurality ofstaples comprises a first plurality of staples comprising a first crownwidth and a second plurality of staples comprising a second crown widthwhich is different than the first crown width.

Example 224

The surgical staple cartridge of Examples 222 or 223, wherein theplurality of staples comprises a first group of staples comprisingstaple legs defining a first height and a second group of staplescomprising staple legs defining a second height different than the firstheight.

Example 225

The surgical staple cartridge of Example 222, wherein the strip ofstaples comprises a uniform composition.

Example 226

The surgical staple cartridge of Examples 222, 223, 224, or 225, whereinthe strip comprises alignment features configured to engagecorresponding alignment features on the cartridge body.

Example 227

The surgical staple cartridge of Example 222, 223, 224, 225, or 226,further comprising a second strip of staples comprising a plurality ofsecond staples, a second strip, and a plurality of second connectorportions joining the second staples to the second strip, wherein theplurality of staples are arranged in a plurality of rows defining afirst row spacing, wherein the plurality of second staples are arrangedin a plurality of second rows defining a second row spacing, and whereinthe first row spacing and the second row spacing are different.

Example 228

A metal strip of surgical staples configured for use with a surgicalstaple cartridge, the metal strip of surgical staples comprising aplurality of staples, a ribbon, and a plurality of connector portionsjoining the staples to the ribbon.

Example 229

The metal strip of surgical staples of Example 228, wherein theconnector portions comprise a discontinuity notch.

Example 230

A surgical staple cartridge for use with a circular stapler, thesurgical staple cartridge comprising a cartridge body, a plurality ofstaple cavities defined in the cartridge body, and a plurality ofstaples removably stored within the staple cavities, the plurality ofstaples comprising an inner row of staples comprising a quantity offirst staples, wherein each first staple comprises a first staple crowndefining a first staple crown width, an intermediate row of staplespositioned radially outward with respect to the inner row of staples,wherein the intermediate row of staples comprises a quantity of secondstaples, and wherein each second staple comprises a second staple crowndefining a second staple crown width, and an outer row of staplespositioned radially outward with respect to the intermediate row ofstaples, wherein the outer row of staples comprises a quantity of thirdstaples, wherein each third staple comprises a third staple crowndefining a third staple crown width, and wherein one of the first staplecrown width, the second staple crown width, and the third staple crownwidth is different than another of the first staple crown width, thesecond staple crown width, and the third staple crown width.

Example 231

The surgical staple cartridge of Example 230, wherein the inner row ofstaples defines a plurality of first gaps between the first staples, andwherein the second staples of the intermediate row of staples overlapthe first gaps.

Example 232

The surgical staple cartridge of Example 231, wherein the intermediaterow of staples defines a plurality of second gaps between the secondstaples, wherein the second gaps are larger than the first gaps, andwherein the third staples of the outer row of staples overlap the secondgaps.

Example 233

The surgical staple cartridge of Examples 231 or 232, wherein the thirdstaples of the outer row of staples also overlap the first gaps.

Example 234

The surgical staple cartridge of Example 230, wherein the inner row ofstaples defines a plurality of first gaps between the first staples,wherein the intermediate row of staples defines a plurality of secondgaps between the second staples, wherein the second staples overlap thefirst gaps, and wherein the first gaps and the second gaps are at leastsubstantially equal.

Example 235

The surgical staple cartridge of Example 230, wherein the inner row ofstaples defines a plurality of first gaps between the first staples,wherein the intermediate row of staples defines a plurality of secondgaps between the second staples, wherein each first gap defines a firstdistance, and wherein each second gap defines a second distance which isless than the first distance.

Example 236

The surgical staple cartridge of Examples 230, 231, 232, 233, 234, or235, wherein the first staple crown width is less than the second staplecrown width.

Example 237

The surgical staple cartridge of Examples 230, 231, 232, 233, 234, or235, wherein the first staple crown width is at least substantiallyequal to the second staple crown width.

Example 238

The surgical staple cartridge of Examples 230, 231, 232, 233, 234, 235,236, or 237, wherein the third staple crown width is greater than thefirst staple crown width and the second staple crown width.

Example 239

A surgical staple cartridge for use with a circular stapler, thesurgical staple cartridge comprising a cartridge body, a plurality ofstaple cavities defined in the cartridge body, and a plurality ofstaples removably stored within the staple cavities, the plurality ofstaples comprising an inner row of staples comprising a first quantityof first staples, wherein each first staple comprises a first staplecrown defining a first staple crown width, an intermediate row ofstaples positioned radially outward with respect to the inner row ofstaples, wherein the intermediate row of staples comprises a secondquantity of second staples, and wherein each second staple comprises asecond staple crown defining a second staple crown width, and an outerrow of staples positioned radially outward with respect to theintermediate row of staples, wherein the outer row of staples comprisesa third quantity of third staples, wherein each third staple comprises athird staple crown defining a third staple crown width, wherein one ofthe first staple crown width, the second staple crown width, and thethird staple crown width is different than another of the first staplecrown width, the second staple crown width, and the third staple crownwidth, and wherein one of the first quantity, the second quantity, andthe third quantity is different than another of the first quantity, thesecond quantity, and the third quantity.

Example 240

The surgical staple cartridge of Example 239, wherein the secondquantity is less than the first quantity.

Example 241

The surgical staple cartridge of Examples 239 or 240, wherein the secondquantity is less than the third quantity.

Example 242

The surgical staple cartridge of Examples 239, 240, or 241, wherein theplurality of staple cavities comprises a plurality of non-uniform cavityextenders.

Example 243

The surgical staple cartridge of Examples 239, 240, 241, or 242, whereineach first staple of the inner row of staples comprises a pair of staplelegs extending radially outward from each first staple crown.

Example 244

The surgical staple cartridge of Examples 239, 240, 241, 242, or 243,wherein each second staple of the intermediate row of staples comprisesa pair of staple legs extending radially inward from each second staplecrown.

Example 245

The surgical staple cartridge of Examples 239, 240, 241, 242, 243, or244, wherein each third staple of the outer row of staples comprises apair of staple legs extending radially inward from each third staplecrown.

Example 246

A surgical staple cartridge for use with a surgical stapler, thesurgical staple cartridge comprising a cartridge body, a plurality ofstaple cavities defined in the cartridge body, and a plurality ofstaples removably stored within the staple cavities, the plurality ofstaples comprising an inner row of staples comprising a first quantityof first staples, wherein each first staple comprises a first staplecrown defining a first staple crown width, an intermediate row ofstaples positioned outward with respect to the inner row of staples,wherein the intermediate row of staples comprises a second quantity ofsecond staples, and wherein each second staple comprises a second staplecrown defining a second staple crown width, and an outer row of staplespositioned outward with respect to the intermediate row of staples,wherein the outer row of staples comprises a third quantity of thirdstaples, wherein each third staple comprises a third staple crowndefining a third staple crown width, and wherein one of the first staplecrown width, the second staple crown width, and the third staple crownwidth is different than another of the first staple crown width, thesecond staple crown width, and the third staple crown width.

Example 247

The surgical staple cartridge of Example 246, wherein one of the firstquantity, the second quantity, and the third quantity is different thananother of the first quantity, the second quantity, and the thirdquantity.

Example 248

The surgical staple cartridge of Example 246, wherein the first quantityand the second quantity are equal.

Example 249

The surgical staple cartridge of Examples 246, 247, or 248, wherein theinner row of staples defines a plurality of first gaps between the firststaples, wherein the intermediate row of staples defines a plurality ofsecond gaps between the second staples, wherein each first gap defines afirst distance, and wherein each second gap defines a second distancewhich is less than the first distance.

The entire disclosures of:

U.S. Pat. No. 5,403,312, entitled ELECTROSURGICAL HEMOSTATIC DEVICE,which issued on Apr. 4, 1995;

U.S. Pat. No. 7,000,818, entitled SURGICAL STAPLING INSTRUMENT HAVINGSEPARATE DISTINCT CLOSING AND FIRING SYSTEMS, which issued on Feb. 21,2006;

U.S. Pat. No. 7,422,139, entitled MOTOR-DRIVEN SURGICAL CUTTING ANDFASTENING INSTRUMENT WITH TACTILE POSITION FEEDBACK, which issued onSep. 9, 2008;

U.S. Pat. No. 7,464,849, entitled ELECTRO-MECHANICAL SURGICAL INSTRUMENTWITH CLOSURE SYSTEM AND ANVIL ALIGNMENT COMPONENTS, which issued on Dec.16, 2008;

U.S. Pat. No. 7,670,334, entitled SURGICAL INSTRUMENT HAVING ANARTICULATING END EFFECTOR, which issued on Mar. 2, 2010;

U.S. Pat. No. 7,753,245, entitled SURGICAL STAPLING INSTRUMENTS, whichissued on Jul. 13, 2010;

U.S. Pat. No. 8,393,514, entitled SELECTIVELY ORIENTABLE IMPLANTABLEFASTENER CARTRIDGE, which issued on Mar. 12, 2013;

U.S. patent application Ser. No. 11/343,803, entitled SURGICALINSTRUMENT HAVING RECORDING CAPABILITIES, now U.S. Pat. No. 7,845,537;

U.S. patent application Ser. No. 12/031,573, entitled SURGICAL CUTTINGAND FASTENING INSTRUMENT HAVING RF ELECTRODES, filed Feb. 14, 2008;

U.S. patent application Ser. No. 12/031,873, entitled END EFFECTORS FORA SURGICAL CUTTING AND STAPLING INSTRUMENT, filed Feb. 15, 2008, nowU.S. Pat. No. 7,980,443;

U.S. patent application Ser. No. 12/235,782, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT, now U.S. Pat. No. 8,210,411;

U.S. patent application Ser. No. 12/249,117, entitled POWERED SURGICALCUTTING AND STAPLING APPARATUS WITH MANUALLY RETRACTABLE FIRING SYSTEM,now U.S. Pat. No. 8,608,045;

U.S. patent application Ser. No. 12/647,100, entitled MOTOR-DRIVENSURGICAL CUTTING INSTRUMENT WITH ELECTRIC ACTUATOR DIRECTIONAL CONTROLASSEMBLY, filed Dec. 24, 2009, now U.S. Pat. No. 8,220,688;

U.S. patent application Ser. No. 12/893,461, entitled STAPLE CARTRIDGE,filed Sep. 29, 2012, now U.S. Pat. No. 8,733,613;

U.S. patent application Ser. No. 13/036,647, entitled SURGICAL STAPLINGINSTRUMENT, filed Feb. 28, 2011, now U.S. Pat. No. 8,561,870;

U.S. patent application Ser. No. 13/118,241, entitled SURGICAL STAPLINGINSTRUMENTS WITH ROTATABLE STAPLE DEPLOYMENT ARRANGEMENTS, now U.S. Pat.No. 9,072,535;

U.S. patent application Ser. No. 13/524,049, entitled ARTICULATABLESURGICAL INSTRUMENT COMPRISING A FIRING DRIVE, filed on Jun. 15, 2012,now U.S. Pat. No. 9,101,358;

U.S. patent application Ser. No. 13/800,025, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. Pat.No. 9,345,481;

U.S. patent application Ser. No. 13/800,067, entitled STAPLE CARTRIDGETISSUE THICKNESS SENSOR SYSTEM, filed on Mar. 13, 2013, now U.S. PatentApplication Publication No. 2014/0263552;

U.S. Patent Application Publication No. 2007/0175955, entitled SURGICALCUTTING AND FASTENING INSTRUMENT WITH CLOSURE TRIGGER LOCKING MECHANISM,filed Jan. 31, 2006; and

U.S. Patent Application Publication No. 2010/0264194, entitled SURGICALSTAPLING INSTRUMENT WITH AN ARTICULATABLE END EFFECTOR, filed Apr. 22,2010, now U.S. Pat. No. 8,308,040, are hereby incorporated by referenceherein.

Although the various embodiments of the devices have been describedherein in connection with certain disclosed embodiments, manymodifications and variations to those embodiments may be implemented.Also, where materials are disclosed for certain components, othermaterials may be used. Furthermore, according to various embodiments, asingle component may be replaced by multiple components, and multiplecomponents may be replaced by a single component, to perform a givenfunction or functions. The foregoing description and following claimsare intended to cover all such modification and variations.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

By way of example only, aspects described herein may be processed beforesurgery. First, a new or used instrument may be obtained and whennecessary cleaned. The instrument may then be sterilized. In onesterilization technique, the instrument is placed in a closed and sealedcontainer, such as a plastic or TYVEK bag. The container and instrumentmay then be placed in a field of radiation that can penetrate thecontainer, such as gamma radiation, x-rays, or high-energy electrons.The radiation may kill bacteria on the instrument and in the container.The sterilized instrument may then be stored in the sterile container.The sealed container may keep the instrument sterile until it is openedin a medical facility. A device also may be sterilized using any othertechnique known in the art, including but not limited to beta or gammaradiation, ethylene oxide, plasma peroxide, or steam.

While this invention has been described as having exemplary designs, thepresent invention may be further modified within the spirit and scope ofthe disclosure. This application is therefore intended to cover anyvariations, uses, or adaptations of the invention using its generalprinciples.

Any patent, publication, or other disclosure material, in whole or inpart, that is said to be incorporated by reference herein isincorporated herein only to the extent that the incorporated materialsdoes not conflict with existing definitions, statements, or otherdisclosure material set forth in this disclosure. As such, and to theextent necessary, the disclosure as explicitly set forth hereinsupersedes any conflicting material incorporated herein by reference.Any material, or portion thereof, that is said to be incorporated byreference herein, but which conflicts with existing definitions,statements, or other disclosure material set forth herein will only beincorporated to the extent that no conflict arises between thatincorporated material and the existing disclosure material.

1. A surgical staple cartridge for use with a surgical staplinginstrument, said surgical staple cartridge comprising: a cartridge body;a plurality of staple cavities; and a plurality of staples removablystored within said staple cavities, wherein each said staple comprises:a staple base; and a pair of staple legs extending from said staplebase, wherein each said staple leg comprises a staple tip, wherein saidstaple legs comprise a first zone comprising a first hardness, andwherein said staple tips comprise a second zone comprising a secondhardness which is different that said first hardness.
 2. The surgicalstaple cartridge of claim 1, wherein said second hardness is greaterthan said first hardness.
 3. The surgical staple cartridge of claim 1,wherein said second hardness is less than said first hardness.
 4. Thesurgical staple cartridge of claim 1, wherein said staple base comprisesa third zone comprising a third hardness different than said firsthardness and said second hardness.
 5. The surgical staple cartridge ofclaim 1, wherein said staple legs comprise corner portions that arecoined to said first hardness.
 6. The surgical staple cartridge of claim5, wherein said corner portions provide a preferential bending plane. 7.The surgical staple cartridge of claim 1, wherein said first zonecomprises a first ductility, and wherein said second zone comprises asecond ductility which is less than said first ductility.
 8. A surgicalstaple cartridge for use with a surgical stapling instrument, saidsurgical staple cartridge comprising: a cartridge body; a plurality ofstaple cavities; and a plurality of staples removably stored within saidstaple cavities, wherein each said staple comprises: a staple base; apair of staple legs extending from said staple base; a first zonecomprising a first hardness; and a second zone comprising a secondhardness which is different that said first hardness.
 9. The surgicalstaple cartridge of claim 8, wherein said first zone is hardened using afirst method and said second zone is hardened using a second methoddifferent than said first method.
 10. The surgical staple cartridge ofclaim 8, wherein only one of said first zone and said second zone ishardened by a hardening method.
 11. The surgical staple cartridge ofclaim 8, wherein each said staple further comprises bend portionsintermediate said staple legs and said staple base, and wherein saidbend portions comprise said first zone and said staple base comprisessaid second zone.
 12. The surgical staple cartridge of claim 8, whereinsaid staple base comprises said first zone and said staple legs comprisesaid second zone.
 13. The surgical staple cartridge of claim 12, whereinsaid staple legs are not hardened and said staple base is hardened suchthat said staple legs are encouraged to assume a formed configurationand such that said staple base is configured to avoid plasticdeformation.
 14. The surgical staple of claim 5, wherein each saidstaple leg comprises a transition portion extending from said staplebase and a vertical leg portion extending from said transition portion,and wherein said staple base comprises said first zone and said verticalleg portion comprises said second zone.
 15. A surgical staple configuredto be removably stored within a surgical staple cartridge in an unfiredconfiguration, said surgical staple comprising a non-uniform hardnessprofile, wherein said staple comprises a first zone having a firsthardness and a second zone having a second hardness, wherein said firstzone is hardened to said first hardness when said staple is in apre-load configuration, and wherein said second zone is hardened to saidsecond hardness when said staple is in the pre-load configuration.16-19. (canceled)